Trial Outcomes & Findings for Minimal Opioid Use After Total Hip Replacement (THR) (NCT NCT03090152)
NCT ID: NCT03090152
Last Updated: 2024-12-27
Results Overview
Oral morphine equivalents, cumulative
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
180 participants
Primary outcome timeframe
within 24 hours after surgery
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Periarticular Injection (PAI)
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
60
|
|
Overall Study
COMPLETED
|
59
|
56
|
59
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
1
|
Reasons for withdrawal
| Measure |
Periarticular Injection (PAI)
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
|
Overall Study
Surgery Canceled
|
1
|
0
|
0
|
|
Overall Study
Epidural catheter could not be placed
|
0
|
2
|
0
|
Baseline Characteristics
Minimal Opioid Use After Total Hip Replacement (THR)
Baseline characteristics by cohort
| Measure |
Periarticular Injection (PAI)
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=56 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 8 • n=5 Participants
|
64 years
STANDARD_DEVIATION 7 • n=7 Participants
|
64 years
STANDARD_DEVIATION 7 • n=5 Participants
|
64 years
STANDARD_DEVIATION 7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
165 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
56 participants
n=7 Participants
|
59 participants
n=5 Participants
|
174 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: within 24 hours after surgeryOral morphine equivalents, cumulative
Outcome measures
| Measure |
Periarticular Injection (PAI)
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=56 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Opioid Use
|
30 Oral Morphine Equivalent (mg)
Interval 15.0 to 45.0
|
22.5 Oral Morphine Equivalent (mg)
Interval 7.5 to 45.0
|
15 Oral Morphine Equivalent (mg)
Interval 7.5 to 30.0
|
SECONDARY outcome
Timeframe: Postoperative Day 1,2,3,7,90NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.
Outcome measures
| Measure |
Periarticular Injection (PAI)
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=56 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Pain at Rest
POD1
|
2 score on a scale
Standard Deviation 1.9
|
1.9 score on a scale
Standard Deviation 1.8
|
1.7 score on a scale
Standard Deviation 1.8
|
|
Pain at Rest
POD2
|
2.2 score on a scale
Standard Deviation 2
|
1.8 score on a scale
Standard Deviation 1.9
|
1.9 score on a scale
Standard Deviation 1.8
|
|
Pain at Rest
POD3
|
1.8 score on a scale
Standard Deviation 1.6
|
1.2 score on a scale
Standard Deviation 1.5
|
1.3 score on a scale
Standard Deviation 1.4
|
|
Pain at Rest
POD7
|
1.5 score on a scale
Standard Deviation 1.8
|
1.1 score on a scale
Standard Deviation 1.4
|
1.5 score on a scale
Standard Deviation 1.7
|
|
Pain at Rest
POD90
|
0.3 score on a scale
Standard Deviation 0.8
|
0.3 score on a scale
Standard Deviation 0.7
|
0.6 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Postoperative Day 1,2,3,7,90NRS (Numeric Pain Rating Scale). 0 means no pain, 10 means worst pain imaginable. A lower score is a better outcome.
Outcome measures
| Measure |
Periarticular Injection (PAI)
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=56 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Pain With Activity
POD1
|
3.6 score on a scale
Standard Deviation 2.4
|
3.4 score on a scale
Standard Deviation 2.3
|
3.7 score on a scale
Standard Deviation 2.6
|
|
Pain With Activity
POD2
|
4.2 score on a scale
Standard Deviation 2.3
|
3.6 score on a scale
Standard Deviation 2.5
|
4 score on a scale
Standard Deviation 2.1
|
|
Pain With Activity
POD3
|
3.8 score on a scale
Standard Deviation 2.5
|
3.2 score on a scale
Standard Deviation 2.2
|
3.2 score on a scale
Standard Deviation 2.1
|
|
Pain With Activity
POD7
|
2.8 score on a scale
Standard Deviation 2.1
|
2.7 score on a scale
Standard Deviation 1.9
|
3 score on a scale
Standard Deviation 2
|
|
Pain With Activity
POD90
|
0.7 score on a scale
Standard Deviation 1.2
|
0.6 score on a scale
Standard Deviation 1.2
|
1.4 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Postoperative Day 1,2via ORSDS (Opioid-Related Symptom Distress Scale). Each symptom was rated on a 4 point scale from 0-4. A lower score is a better outcome.
Outcome measures
| Measure |
Periarticular Injection (PAI)
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=56 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Opioid Side Effects
POD1- Fatigue
|
0.8 score on a scale
Standard Deviation 1.2
|
0.6 score on a scale
Standard Deviation 0.9
|
0.9 score on a scale
Standard Deviation 1.1
|
|
Opioid Side Effects
POD1- Drowsiness
|
1.1 score on a scale
Standard Deviation 1
|
0.6 score on a scale
Standard Deviation 0.9
|
1.3 score on a scale
Standard Deviation 1.1
|
|
Opioid Side Effects
POD1- Inability to Concentrate
|
0.2 score on a scale
Standard Deviation 0.6
|
0.1 score on a scale
Standard Deviation 0.5
|
0.3 score on a scale
Standard Deviation 0.8
|
|
Opioid Side Effects
POD1- Nausea
|
0.7 score on a scale
Standard Deviation 1.2
|
0.3 score on a scale
Standard Deviation 0.7
|
0.6 score on a scale
Standard Deviation 1
|
|
Opioid Side Effects
POD1- Dizziness
|
0.4 score on a scale
Standard Deviation 0.7
|
0.5 score on a scale
Standard Deviation 1
|
0.9 score on a scale
Standard Deviation 1
|
|
Opioid Side Effects
POD1- Constipation
|
0.2 score on a scale
Standard Deviation 0.6
|
0.5 score on a scale
Standard Deviation 1
|
0.4 score on a scale
Standard Deviation 0.8
|
|
Opioid Side Effects
POD2- Fatigue
|
0.7 score on a scale
Standard Deviation 1
|
0.7 score on a scale
Standard Deviation 1.1
|
1 score on a scale
Standard Deviation 1.2
|
|
Opioid Side Effects
POD2- Drowsiness
|
1 score on a scale
Standard Deviation 1
|
0.7 score on a scale
Standard Deviation 1
|
1.2 score on a scale
Standard Deviation 1.1
|
|
Opioid Side Effects
POD2- Inability to Concentrate
|
0.2 score on a scale
Standard Deviation 0.6
|
0.1 score on a scale
Standard Deviation 0.4
|
0.3 score on a scale
Standard Deviation 0.8
|
|
Opioid Side Effects
POD2- Nausea
|
0.2 score on a scale
Standard Deviation 0.6
|
0.3 score on a scale
Standard Deviation 0.9
|
0.6 score on a scale
Standard Deviation 1.1
|
|
Opioid Side Effects
POD2-Dizziness
|
0.4 score on a scale
Standard Deviation 0.8
|
0.4 score on a scale
Standard Deviation 0.9
|
0.6 score on a scale
Standard Deviation 1.1
|
|
Opioid Side Effects
POD2- Constipation
|
0.7 score on a scale
Standard Deviation 1.1
|
0.7 score on a scale
Standard Deviation 1.1
|
1 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Postoperative Day 1,2,3,7via Likert scale. A higher score is a better outcome. the scale is from 0-10.
Outcome measures
| Measure |
Periarticular Injection (PAI)
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=56 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Patient Satisfaction
POD7
|
9.6 score on a scale
Standard Deviation 0.9
|
9.4 score on a scale
Standard Deviation 0.8
|
8.9 score on a scale
Standard Deviation 2.2
|
|
Patient Satisfaction
POD1
|
9.6 score on a scale
Standard Deviation 1.3
|
9.6 score on a scale
Standard Deviation 0.8
|
9.5 score on a scale
Standard Deviation 1.1
|
|
Patient Satisfaction
POD2
|
9.3 score on a scale
Standard Deviation 1.5
|
9.1 score on a scale
Standard Deviation 1.5
|
9.1 score on a scale
Standard Deviation 1.2
|
|
Patient Satisfaction
POD3
|
9.5 score on a scale
Standard Deviation 1
|
9.1 score on a scale
Standard Deviation 1.5
|
9.1 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Postoperative Day 1Population: some patients were lost to follow up or did not answer questionnaire.
via PAINOUT (Improvement in postoperative PAIN OUTcome) Minumum value is zero, maximum is ten. Higher scores mean worse outcomes.
Outcome measures
| Measure |
Periarticular Injection (PAI)
n=58 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=55 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=56 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Post-operative Pain
The worst pain you had in the last 24 hours
|
5.5 score on a scale
Interval 2.0 to 7.0
|
5 score on a scale
Interval 3.0 to 7.0
|
4 score on a scale
Interval 2.0 to 7.0
|
|
Post-operative Pain
The least pain you had in the last 24 hours
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 2.0
|
|
Post-operative Pain
How often were you in severe pain in the last 24 hours?
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
1 score on a scale
Interval 1.0 to 3.0
|
|
Post-operative Pain
How much pain interfered with doing activities in bed like turning, sitting up, changing position?
|
1 score on a scale
Interval 0.0 to 3.0
|
2 score on a scale
Interval 0.0 to 5.0
|
1 score on a scale
Interval 0.0 to 3.0
|
|
Post-operative Pain
How much pain interfered with or prevented you from breathing deeply or coughing?
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Post-operative Pain
How much pain interfered with or prevented you from sleeping?
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Post-operative Pain
How much pain interfered with doing activities out of bed?
|
2 score on a scale
Interval 0.0 to 4.0
|
2 score on a scale
Interval 0.0 to 5.0
|
2 score on a scale
Interval 0.0 to 4.0
|
|
Post-operative Pain
In the last 24 hours, have you had any nausea?
|
0 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 3.0
|
|
Post-operative Pain
In the last 24 hours, have you had any drowsiness?
|
2.5 score on a scale
Interval 0.0 to 5.0
|
0 score on a scale
Interval 0.0 to 3.0
|
3 score on a scale
Interval 0.0 to 5.0
|
|
Post-operative Pain
In the last 24 hours, have you had any itching?
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Postoperative Day 7, Postoperative Day 90Population: some patients were Lost to Follow up or did not answer questionnaire.
via S-LANSS (Self-report Leeds Assessment of Neuropathic Symptoms and Signs). Scores range from 0-24. A lower score is a better outcome.
Outcome measures
| Measure |
Periarticular Injection (PAI)
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=56 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=58 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Neuropathic Pain Assessed With S-LANSS
POD7
|
8 score on a scale
Interval 5.0 to 8.0
|
8 score on a scale
Interval 5.0 to 8.0
|
7.5 score on a scale
Interval 5.0 to 8.0
|
|
Neuropathic Pain Assessed With S-LANSS
POD90
|
8 score on a scale
Interval 8.0 to 8.0
|
8 score on a scale
Interval 8.0 to 8.0
|
8 score on a scale
Interval 8.0 to 8.0
|
SECONDARY outcome
Timeframe: Postoperative Day 1,2,3Population: Lost to follow up
Via QoR-40 (Quality of Recovery). Minimum value of 40, maximum of 200. Higher values mean better outcome
Outcome measures
| Measure |
Periarticular Injection (PAI)
n=58 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=54 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=58 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Quality of Recovery
POD1
|
102.2 score on a scale
Standard Deviation 6.6
|
102.3 score on a scale
Standard Deviation 5.9
|
101.6 score on a scale
Standard Deviation 6.8
|
|
Quality of Recovery
POD2
|
102.9 score on a scale
Standard Deviation 7.4
|
103.1 score on a scale
Standard Deviation 7.4
|
102.1 score on a scale
Standard Deviation 7.8
|
|
Quality of Recovery
POD3
|
100.7 score on a scale
Standard Deviation 7
|
98.5 score on a scale
Standard Deviation 8.9
|
98.4 score on a scale
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: From end of surgery until the date/time of first documented clearance for discharge, assessed up to 1 week.When patient meets all readiness for discharge criteria
Outcome measures
| Measure |
Periarticular Injection (PAI)
n=58 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=56 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Readiness for Discharge Time
|
46.5 hours
Interval 27.8 to 49.9
|
48.7 hours
Interval 30.7 to 51.1
|
48.8 hours
Interval 43.9 to 51.2
|
SECONDARY outcome
Timeframe: Assessed on day of discharge and on seventh post operative dayPopulation: Lost to follow up
What group do you think you were in
Outcome measures
| Measure |
Periarticular Injection (PAI)
n=50 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=52 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=51 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Blinding Assessment
Discharge · PAI
|
5 Participants
|
13 Participants
|
7 Participants
|
|
Blinding Assessment
Discharge · EPCA
|
10 Participants
|
10 Participants
|
6 Participants
|
|
Blinding Assessment
Discharge · PAI+EPCA
|
18 Participants
|
11 Participants
|
15 Participants
|
|
Blinding Assessment
Discharge · Do Not Know
|
17 Participants
|
18 Participants
|
23 Participants
|
|
Blinding Assessment
POD7 · PAI
|
6 Participants
|
8 Participants
|
7 Participants
|
|
Blinding Assessment
POD7 · EPCA
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Blinding Assessment
POD7 · PAI+EPCA
|
17 Participants
|
16 Participants
|
13 Participants
|
|
Blinding Assessment
POD7 · Do Not Know
|
17 Participants
|
18 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Postoperative day 0,1,2,3Opioids consumed in the first 3 after surgery (cumulative consumption).
Outcome measures
| Measure |
Periarticular Injection (PAI)
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=56 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
Opioid Consumption During the First 3 Days Post-op
|
52.5 Oral Morphine Equivalent (mg)
Interval 22.5 to 105.0
|
45 Oral Morphine Equivalent (mg)
Interval 15.0 to 105.0
|
40 Oral Morphine Equivalent (mg)
Interval 15.0 to 85.0
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-operativelyNumber of patients who did not consume any opioids
Outcome measures
| Measure |
Periarticular Injection (PAI)
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Peri-articular injection in the operating room
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that includes EPCA (saline) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Placebo: EPCA: Saline.
|
Epidural Patient-Controlled Analg (EPCA)
n=56 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine patch prior to surgery.
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* A pain regimen while in the hospital that consists of Epidural PCA (EPCA) with 0.06% bupivacaine. Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
PAI + EPCA
n=59 Participants
* Aspirin and nerve pain medications including duloxetine and clonidine
* Combined Spinal Epidural with 1.5% Mepivacaine 4cc
* Anesthetic, Antiemetic and peri-articular injection in the operating room
* A pain regimen while in the hospital that consists of EPCA (with 0.06% bupivacaine) Duloxetine (Cymbalta) - by mouth Ketorolac (Toradol) - IV Celecoxib (Celebrex) - by mouth Acetaminophen (Tylenol) - IV The EPCA will be removed when pain is well-controlled. Other medications, including opioids, will be available.
* Acetaminophen and celecoxib for pain control once out of the hospital. Patients will also receive a prescription for an opioid medication in case they need it.
Periarticular injection (Deep injection): Deep injection of "cocktail" containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata.
Periarticular injection (Superficial injection): Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
Bupivacaine: EPCA: Bupivacaine 0.06%.
|
|---|---|---|---|
|
No Opioids Consumed
|
5 participants
|
12 participants
|
14 participants
|
Adverse Events
Periarticular Injection (PAI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Epidural Patient-Controlled Analg (EPCA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PAI + EPCA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place