Trial Outcomes & Findings for Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty (NCT NCT03408483)
NCT ID: NCT03408483
Last Updated: 2021-06-09
Results Overview
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with \*ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) \*ADL=Activities of Daily Living
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
80 participants
Primary outcome timeframe
Assessed between immediately postoperatively to 12 hours postoperatively
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
Quadratus Lumborum Block (QLB)
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
Quadratus Lumborum Block (QLB): Under ultrasound guidance, the needle will be advanced to the posterior border of the quadratus lumborum muscle. After negative aspiration, a bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots, ensuring proper placement of needle
|
Standard of Care
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
38
|
|
Overall Study
COMPLETED
|
36
|
35
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Quadratus Lumborum Block (QLB)
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
Quadratus Lumborum Block (QLB): Under ultrasound guidance, the needle will be advanced to the posterior border of the quadratus lumborum muscle. After negative aspiration, a bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots, ensuring proper placement of needle
|
Standard of Care
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty
Baseline characteristics by cohort
| Measure |
Quadratus Lumborum Block (QLB)
n=36 Participants
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
|
Standard of Care
n=35 Participants
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.61 years
STANDARD_DEVIATION 2.74 • n=5 Participants
|
58.00 years
STANDARD_DEVIATION 2.06 • n=7 Participants
|
58.305 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
35 participants
n=7 Participants
|
71 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed between immediately postoperatively to 12 hours postoperativelyPopulation: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with \*ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) \*ADL=Activities of Daily Living
Outcome measures
| Measure |
Quadratus Lumborum Block (QLB)
n=36 Participants
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
|
Standard of Care
n=35 Participants
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Pain Scores Using Visual Analog Scale (VAS) Scores
|
2.34 units on a scale
Standard Error 0.46
|
3.33 units on a scale
Standard Error 0.56
|
PRIMARY outcome
Timeframe: Assessed between immediately postoperatively to 24 hours postoperativelyPopulation: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with \*ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) \*ADL=Activities of Daily Living
Outcome measures
| Measure |
Quadratus Lumborum Block (QLB)
n=36 Participants
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
|
Standard of Care
n=35 Participants
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Pain Scores Using Visual Analog Scale (VAS) Scores
|
2.31 units on a scale
Standard Error 0.37
|
4.06 units on a scale
Standard Error 0.42
|
PRIMARY outcome
Timeframe: Assessed between immediately postoperatively to 48 hours postoperativelyPopulation: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with \*ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) \*ADL=Activities of Daily Living
Outcome measures
| Measure |
Quadratus Lumborum Block (QLB)
n=35 Participants
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
|
Standard of Care
n=36 Participants
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Pain Scores Using Visual Analog Scale (VAS) Scores
|
3.33 units on a scale
Standard Error 0.43
|
4.11 units on a scale
Standard Error 0.64
|
PRIMARY outcome
Timeframe: from 24 hours to 48 hours postoperativelyPopulation: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
Total oral morphine equivalent consumption calculated
Outcome measures
| Measure |
Quadratus Lumborum Block (QLB)
n=35 Participants
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
|
Standard of Care
n=36 Participants
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Opioid Consumption (Oral Morphine Equivalents)
|
24.26 mg of morphine equivalents
Standard Error 4.48
|
40.52 mg of morphine equivalents
Standard Error 6.31
|
PRIMARY outcome
Timeframe: immediately postoperatively to 24 hours postoperativelyPopulation: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
Total oral morphine equivalent consumption calculated
Outcome measures
| Measure |
Quadratus Lumborum Block (QLB)
n=35 Participants
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
|
Standard of Care
n=36 Participants
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Opioid Consumption (Oral Morphine Equivalents)
|
30.05 mg of morphine equivalents
Standard Error 3.80
|
47.14 mg of morphine equivalents
Standard Error 4.72
|
PRIMARY outcome
Timeframe: immediately postoperatively to 48 hours postoperativelyPopulation: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
Total oral morphine equivalent consumption calculated
Outcome measures
| Measure |
Quadratus Lumborum Block (QLB)
n=35 Participants
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
|
Standard of Care
n=36 Participants
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Opioid Consumption (Oral Morphine Equivalents)
|
54.63 mg of morphine equivalents
Standard Error 8.25
|
90.76 mg of morphine equivalents
Standard Error 10.65
|
PRIMARY outcome
Timeframe: Immediately postoperatively to 12 hours postoperativelyPopulation: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older: Rating - Pain Level 0 - No Pain 1-3 - Mild Pain (nagging, annoying, interfering little with \*ADLs) 4-6 - Moderate Pain (interferes significantly with ADLs) 7-10 - Severe Pain (disabling; unable to perform ADLs) \*ADL=Activities of Daily Living
Outcome measures
| Measure |
Quadratus Lumborum Block (QLB)
n=36 Participants
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
|
Standard of Care
n=35 Participants
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Pain Scores Using Visual Analog Scale (VAS) Scores
|
2.34 score on a scale
Standard Error 0.46
|
3.33 score on a scale
Standard Error 0.56
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
Patient Satisfaction Score: Determined by patient interview conducted at the 24 hour Time Frame. The interview follows a script requesting current pain level based on a scale of 1-10: 1 = very not satisfied 10 = very satisfied Patient satisfaction is subjective.
Outcome measures
| Measure |
Quadratus Lumborum Block (QLB)
n=35 Participants
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
|
Standard of Care
n=36 Participants
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Patient Satisfaction
|
9.14 score on a scale
Standard Error 0.28
|
7.46 score on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Maximum 96 HoursPopulation: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
From time of the surgical procedure to the time of hospital discharge (measured in hours) up to 3 hours.
Outcome measures
| Measure |
Quadratus Lumborum Block (QLB)
n=35 Participants
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
|
Standard of Care
n=36 Participants
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Hours to Hospital Discharge
|
53.17 hours
Standard Error 4.99
|
55.97 hours
Standard Error 3.78
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
Physical therapist documentation of ambulation distance measured in feet
Outcome measures
| Measure |
Quadratus Lumborum Block (QLB)
n=35 Participants
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
|
Standard of Care
n=36 Participants
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Distance Ambulated
|
127.75 feet
Standard Error 17.33
|
106.69 feet
Standard Error 23.37
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Three patients in each group were excluded for failed spinal anesthesia. Three patients were excluded in the QLB group for missing data due to early discharge.
Physical therapist documentation of ambulation distance measured in feet
Outcome measures
| Measure |
Quadratus Lumborum Block (QLB)
n=35 Participants
* Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.
* After QLB is placed, patients will have THA under spinal anesthesia.
|
Standard of Care
n=36 Participants
* Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
* Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Standard of Care: This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
|
|---|---|---|
|
Distance Ambulated
|
114.51 feet
Standard Error 10.39
|
100.85 feet
Standard Error 10.60
|
Adverse Events
Quadratus Lumborum Block (QLB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
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