Trial Outcomes & Findings for Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK? (NCT NCT04749615)
NCT ID: NCT04749615
Last Updated: 2024-12-27
Results Overview
The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will be asked on post operative discharge day 1.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
94 participants
Primary outcome timeframe
24 hours Post Operative Discharge
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
No PAI + ACB & IPACK
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
|
Overall Study
COMPLETED
|
41
|
37
|
|
Overall Study
NOT COMPLETED
|
6
|
10
|
Reasons for withdrawal
| Measure |
No PAI + ACB & IPACK
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
10
|
Baseline Characteristics
Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK?
Baseline characteristics by cohort
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 6 • n=5 Participants
|
66 years
STANDARD_DEVIATION 7 • n=7 Participants
|
66 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
81 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body Mass Index
|
30 kg/m^2
STANDARD_DEVIATION 3 • n=5 Participants
|
31 kg/m^2
STANDARD_DEVIATION 4 • n=7 Participants
|
30 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
|
American Society of Anesthesiologists Status
ASA 1
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
American Society of Anesthesiologists Status
ASA 2
|
39 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
American Society of Anesthesiologists Status
ASA 3
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours Post Operative DischargeThe NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will be asked on post operative discharge day 1.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
Pain Scores (NRS, 0-10) With Ambulation on POD1
|
4.55 units on a scale
Standard Deviation 2.7
|
4.26 units on a scale
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.Population: At post operative day 14 and 90, the number analyzed differ from the overall number because some subjects were lost to follow up.
Cumulative opioid consumption in morphine equivalents will be recorded post surgical discharge, 24h post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months)
post anesthesia care unit (PACU)
|
25.45 MME/day
Standard Deviation 13.71
|
21.98 MME/day
Standard Deviation 12.02
|
|
Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months)
post operative day (POD) 1
|
25.95 MME/day
Standard Deviation 20.04
|
22.16 MME/day
Standard Deviation 21.17
|
|
Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months)
post operative day (POD) 2
|
37.3 MME/day
Standard Deviation 24.86
|
28.64 MME/day
Standard Deviation 30.21
|
|
Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months)
post operative day (POD) 14
|
6.91 MME/day
Standard Deviation 10.53
|
6.68 MME/day
Standard Deviation 10.4
|
|
Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months)
post operative day (POD) 90
|
0.27 MME/day
Standard Deviation 1.3
|
0.2 MME/day
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 monthsPopulation: the number of participants analyzed at POD 3 months is different due to lost to follow ups
The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain during movement and will be asked at pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
NRS Pain With Movement
Pre-operation
|
5.17 units on a scale
Standard Deviation 2.52
|
5.85 units on a scale
Standard Deviation 2.62
|
|
NRS Pain With Movement
Post anesthesia care unit (PACU)
|
5.7 units on a scale
Standard Deviation 3.11
|
5.19 units on a scale
Standard Deviation 2.92
|
|
NRS Pain With Movement
Post operative day (POD) 1
|
4.55 units on a scale
Standard Deviation 2.7
|
4.26 units on a scale
Standard Deviation 3.03
|
|
NRS Pain With Movement
Post operative day (POD) 2
|
6.68 units on a scale
Standard Deviation 2.29
|
6.13 units on a scale
Standard Deviation 2.62
|
|
NRS Pain With Movement
Post operative day (POD) 3 months
|
1.02 units on a scale
Standard Deviation 1.82
|
0.95 units on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: from pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 monthsPopulation: number of participants analyzed at POD 3 months differed from overall number of participants due to lost to follow up
The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain without movement involved and will be asked at pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
Numerical Rating Scale (NRS) Pain Score at Rest
pre-operation
|
1.19 units on a scale
Standard Deviation 2.05
|
1.79 units on a scale
Standard Deviation 2.8
|
|
Numerical Rating Scale (NRS) Pain Score at Rest
post anesthesia care unit (PACU)
|
5.66 units on a scale
Standard Deviation 3.17
|
5.06 units on a scale
Standard Deviation 2.91
|
|
Numerical Rating Scale (NRS) Pain Score at Rest
post operative day (POD) 1
|
2.36 units on a scale
Standard Deviation 2.29
|
2.47 units on a scale
Standard Deviation 2.86
|
|
Numerical Rating Scale (NRS) Pain Score at Rest
post operative day (POD) 2
|
4.09 units on a scale
Standard Deviation 2.95
|
4.13 units on a scale
Standard Deviation 3.06
|
|
Numerical Rating Scale (NRS) Pain Score at Rest
post operative day (POD) 3 months
|
0.29 units on a scale
Standard Deviation 0.93
|
0.46 units on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: at preoperationThe PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
PAIN OUT Questionnaire at Preoperation
Least pain in 24 hours
|
0.96 score on a scale
Standard Deviation 1.96
|
1.45 score on a scale
Standard Deviation 2.49
|
|
PAIN OUT Questionnaire at Preoperation
Worst pain in 24 hours
|
6.57 score on a scale
Standard Deviation 2.83
|
6.79 score on a scale
Standard Deviation 2.7
|
|
PAIN OUT Questionnaire at Preoperation
Pain interfered or prevented you from activities in bed
|
3.11 score on a scale
Standard Deviation 3.51
|
3.02 score on a scale
Standard Deviation 3.4
|
|
PAIN OUT Questionnaire at Preoperation
Pain interfered or prevented you from activities out of bed
|
5.04 score on a scale
Standard Deviation 3.55
|
5.94 score on a scale
Standard Deviation 3.45
|
|
PAIN OUT Questionnaire at Preoperation
Pain interfered or prevented you from falling asleep
|
2.49 score on a scale
Standard Deviation 3.71
|
3.06 score on a scale
Standard Deviation 4
|
|
PAIN OUT Questionnaire at Preoperation
Pain interfered or prevented you from staying asleep
|
2.49 score on a scale
Standard Deviation 3.71
|
3.06 score on a scale
Standard Deviation 4
|
|
PAIN OUT Questionnaire at Preoperation
How much the pain caused you to feel anxious
|
1.02 score on a scale
Standard Deviation 2.55
|
1.89 score on a scale
Standard Deviation 3.23
|
|
PAIN OUT Questionnaire at Preoperation
How much the pain caused you to feel depressed
|
1.15 score on a scale
Standard Deviation 2.66
|
1.6 score on a scale
Standard Deviation 3.1
|
|
PAIN OUT Questionnaire at Preoperation
How much the pain caused you to feel frightened
|
0.49 score on a scale
Standard Deviation 1.72
|
1.02 score on a scale
Standard Deviation 2.57
|
|
PAIN OUT Questionnaire at Preoperation
How much the pain caused you to feel helpless
|
1.13 score on a scale
Standard Deviation 2.68
|
1.02 score on a scale
Standard Deviation 2.57
|
|
PAIN OUT Questionnaire at Preoperation
Severity of nausea
|
0 score on a scale
Standard Deviation 0
|
5 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Preoperation
Severity of drowsiness
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Preoperation
Severity of itching
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Preoperation
Severity of dizziness
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Preoperation
Were you allowed to participate in decisions about pain treatment?
|
7.5 score on a scale
Standard Deviation 5
|
10 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Preoperation
How satisfied are you with the results of your pain treatment?
|
6.66 score on a scale
Standard Deviation 5.77
|
10 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 24 hours post surgical discharge.Quality of Recovery (QoR-9), This questionnaire has three options for scale (not at all, some of the time, most of the time). The QoR-9 is a nine-item scale. Total QoR-9-scores range from 0 to 18, with higher scores indicating good recovery after anaesthesia. The questions focus on the overall well being of the patient. The questionnaire will be asked 24 hours post surgical discharge.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
Quality of Recovery (POD1)
|
16.62 units on a scale
Standard Deviation 2.31
|
16.96 units on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 24 hours (POD 1) post surgical discharge.The Opioid-related symptom distress scale evaluates frequency, severity, bothersomeness for 12 symptoms. Each symptom is scored on a 4-point scale, with 0 meaning better outcome and 4 meaning worst outcome. The questionnaire will be asked 24 hours (POD 1) post surgical discharge.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
Side Effects: Opioid-Related Symptom Distress Score (POD1)
|
.55 score on a scale
Standard Deviation .97
|
.74 score on a scale
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: 24 hours post operative discharge.This questionnaire is a numeric scale from 0 (strongly dissatisfied) to 10 ( strongly satisfied). A higher number dictates a better outcome. This will be asked 24 hours post operative discharge.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
Satisfaction With Pain Management (POD1)
|
9.7 score on a scale
Standard Deviation .81
|
9.66 score on a scale
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: 24 hours post operative dischargeThere is no numeric scale for this questionnaire. It focuses on asking the subjects and the research assistant, which group they believe the subject were randomized to. This will be asked 24 hours post operative discharge.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
Blinding Assessment; Bang Question (POD1)
Subjects Guess · Guessed that the subject was in the "No PAI+ACB & IPACK" group
|
10 Participants
|
8 Participants
|
|
Blinding Assessment; Bang Question (POD1)
Subjects Guess · Guessed that the subject was in the "PAI+ACB & IPACK" group
|
13 Participants
|
17 Participants
|
|
Blinding Assessment; Bang Question (POD1)
Subjects Guess · Guessed "Don't know"
|
24 Participants
|
22 Participants
|
|
Blinding Assessment; Bang Question (POD1)
Research Assistant Guess · Guessed that the subject was in the "No PAI+ACB & IPACK" group
|
0 Participants
|
3 Participants
|
|
Blinding Assessment; Bang Question (POD1)
Research Assistant Guess · Guessed that the subject was in the "PAI+ACB & IPACK" group
|
4 Participants
|
7 Participants
|
|
Blinding Assessment; Bang Question (POD1)
Research Assistant Guess · Guessed "Don't know"
|
43 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Pre operative, 3 months post operative discharge.Population: The number analyzed at POD 3 months differs from the overall number of participant due to lost to follow up.
The DN4 ( Douleur Neuropathique en 4 Questions) is a Yes/No questionnaire aimed at uncovering neuropathic pain symptoms. Each question is scored as yes or no, with yes = 1 point and no = 0 points. Total score is calculated by summing the total of the individual question scores, for a total score range of 0-10, with a score of greater than or equal to 4 indicating the patient may be suffering from neuropathic pain. The average score across all participants is calculated and reported for each time point.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months
at peroperation
|
2.79 score on a scale
Standard Deviation 1.35
|
2.62 score on a scale
Standard Deviation 1.11
|
|
Douleur Neuropathique en 4 Questions (DN4) at Pre-operation, 3 Months
post operative day (POD) 3 months
|
2.63 score on a scale
Standard Deviation .92
|
2.78 score on a scale
Standard Deviation .92
|
SECONDARY outcome
Timeframe: preoperatively, 6 weeks post operative discharge, 3 months post operative dischargePopulation: The number analyzed at 6 weeks and 3 months differ from the overall number due to lost to follow up
The standard Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.) questionnaire will be asked to evaluate orthopedic outcomes. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health. The questionnaire will be asked preoperatively, 6 weeks post operative discharge, 3 months post operative discharge.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
at preoperation
|
50.7 score on a scale
Standard Deviation 16.2
|
49.61 score on a scale
Standard Deviation 16.57
|
|
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
at 6 weeks
|
78.31 score on a scale
Standard Deviation 11.36
|
77.05 score on a scale
Standard Deviation 12.86
|
|
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
at 3 months
|
83.39 score on a scale
Standard Deviation 13.83
|
83.60 score on a scale
Standard Deviation 9.57
|
SECONDARY outcome
Timeframe: at post operative day (POD) 1The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
Least pain in 24 hours
|
1.17 score on a scale
Standard Deviation 2.05
|
1.34 score on a scale
Standard Deviation 2.55
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
Worst pain in 24 hours
|
6.53 score on a scale
Standard Deviation 2.69
|
6.15 score on a scale
Standard Deviation 2.97
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
Pain interfered or prevented you from activities in bed
|
2.32 score on a scale
Standard Deviation 3.85
|
2.4 score on a scale
Standard Deviation 3.47
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
Pain interfered or prevented you from activities out of bed
|
3.13 score on a scale
Standard Deviation 3.85
|
2.4 score on a scale
Standard Deviation 3.47
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
Pain interfered or prevented you from falling asleep
|
1.06 score on a scale
Standard Deviation 2.63
|
.85 score on a scale
Standard Deviation 2.29
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
Pain interfered or prevented you from staying asleep
|
1.19 score on a scale
Standard Deviation 2.84
|
.96 score on a scale
Standard Deviation 2.64
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
How much the pain caused you to feel anxious
|
.66 score on a scale
Standard Deviation 2.1
|
.23 score on a scale
Standard Deviation .94
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
How much the pain caused you to feel depressed
|
0 score on a scale
Standard Deviation 0
|
.11 score on a scale
Standard Deviation .73
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
How much the pain caused you to feel frightened
|
.32 score on a scale
Standard Deviation 1.62
|
.26 score on a scale
Standard Deviation 1.37
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
How much the pain caused you to feel helpless
|
.32 score on a scale
Standard Deviation 1.62
|
0 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
Severity of nausea
|
6 score on a scale
Standard Deviation 3.59
|
8.57 score on a scale
Standard Deviation 2.9
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
Severity of drowsiness
|
6.64 score on a scale
Standard Deviation 2.69
|
6.72 score on a scale
Standard Deviation 2.91
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
Severity of itching
|
0 score on a scale
Standard Deviation 0
|
2 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
Severity of dizziness
|
4.86 score on a scale
Standard Deviation 3.23
|
6.1 score on a scale
Standard Deviation 3.75
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
Were you allowed to participate in decisions about pain treatment?
|
10 score on a scale
Standard Deviation 0
|
9.76 score on a scale
Standard Deviation 1.46
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1
How satisfied are you with the results of your pain treatment?
|
9.78 score on a scale
Standard Deviation .68
|
9.68 score on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: at post operative day (POD) 14The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=46 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
Least pain in 24 hours
|
1.72 score on a scale
Standard Deviation 2.02
|
1.54 score on a scale
Standard Deviation 2.11
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
Worst pain in 24 hours
|
5.6 score on a scale
Standard Deviation 2.62
|
5.26 score on a scale
Standard Deviation 2.72
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
Pain interfered or prevented you from activities in bed
|
2.68 score on a scale
Standard Deviation 3.33
|
2.09 score on a scale
Standard Deviation 2.98
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
Pain interfered or prevented you from activities out of bed
|
1.81 score on a scale
Standard Deviation 2.7
|
1.7 score on a scale
Standard Deviation 2.46
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
Pain interfered or prevented you from falling asleep
|
3.02 score on a scale
Standard Deviation 3.92
|
2.85 score on a scale
Standard Deviation 3.88
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
Pain interfered or prevented you from staying asleep
|
3.15 score on a scale
Standard Deviation 4.13
|
3.26 score on a scale
Standard Deviation 3.96
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
How much the pain caused you to feel anxious
|
.66 score on a scale
Standard Deviation 2.18
|
.54 score on a scale
Standard Deviation 1.86
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
How much the pain caused you to feel depressed
|
.38 score on a scale
Standard Deviation 1.64
|
.59 score on a scale
Standard Deviation 1.83
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
How much the pain caused you to feel frightened
|
.09 score on a scale
Standard Deviation .58
|
.07 score on a scale
Standard Deviation .44
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
How much the pain caused you to feel helpless
|
.23 score on a scale
Standard Deviation 1.03
|
.07 score on a scale
Standard Deviation .44
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
Severity of nausea
|
5.5 score on a scale
Standard Deviation 2.08
|
0 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
Severity of drowsiness
|
6 score on a scale
Standard Deviation 4.58
|
4.4 score on a scale
Standard Deviation 1.52
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
Severity of itching
|
3.5 score on a scale
Standard Deviation .71
|
4.71 score on a scale
Standard Deviation 2.81
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
Severity of dizziness
|
0 score on a scale
Standard Deviation 0
|
3 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
Were you allowed to participate in decisions about pain treatment?
|
9.76 score on a scale
Standard Deviation 1.02
|
10 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14
How satisfied are you with the results of your pain treatment?
|
9.61 score on a scale
Standard Deviation .89
|
9.71 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: at post operative day (POD) 90The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=41 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=37 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
Least pain in 24 hours
|
.05 score on a scale
Standard Deviation .22
|
.24 score on a scale
Standard Deviation .86
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
Worst pain in 24 hours
|
1.68 score on a scale
Standard Deviation 2.18
|
1.81 score on a scale
Standard Deviation 2.15
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
Pain interfered or prevented you from activities in bed
|
.29 score on a scale
Standard Deviation .98
|
.89 score on a scale
Standard Deviation 2.13
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
Pain interfered or prevented you from activities out of bed
|
.63 score on a scale
Standard Deviation 1.39
|
.65 score on a scale
Standard Deviation 1.86
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
Pain interfered or prevented you from falling asleep
|
.61 score on a scale
Standard Deviation 1.96
|
.43 score on a scale
Standard Deviation 1.48
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
Pain interfered or prevented you from staying asleep
|
.83 score on a scale
Standard Deviation 2.06
|
.86 score on a scale
Standard Deviation 2.18
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
How much the pain caused you to feel anxious
|
.39 score on a scale
Standard Deviation 1.39
|
.35 score on a scale
Standard Deviation 1.23
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
How much the pain caused you to feel depressed
|
.54 score on a scale
Standard Deviation 2.01
|
.27 score on a scale
Standard Deviation 1.15
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
How much the pain caused you to feel frightened
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
How much the pain caused you to feel helpless
|
0 score on a scale
Standard Deviation 0
|
.14 score on a scale
Standard Deviation .82
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
Severity of nausea
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
Severity of drowsiness
|
3 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
Severity of itching
|
7 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
Severity of dizziness
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
Were you allowed to participate in decisions about pain treatment?
|
9.51 score on a scale
Standard Deviation 2.18
|
10 score on a scale
Standard Deviation 0
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90
How satisfied are you with the results of your pain treatment?
|
9.48 score on a scale
Standard Deviation 1.76
|
9.81 score on a scale
Standard Deviation .87
|
SECONDARY outcome
Timeframe: at preoperationPopulation: preoperative
The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief
Percentage of time in severe pain
|
17.02 percentage of time or relief
Standard Deviation 22.83
|
18.09 percentage of time or relief
Standard Deviation 27.4
|
|
PAIN OUT Questionnaire at Preoperation / Percentage of Time in Severe Pain and Pain Relief
Pain relief in the first 24 hours
|
5.5 percentage of time or relief
Standard Deviation 3.07
|
6.14 percentage of time or relief
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: at post operative day (POD) 1The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief
the percentage of time in severe pain
|
12.55 percentage of time or relief
Standard Deviation 22.98
|
11.49 percentage of time or relief
Standard Deviation 20.74
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 1 / Percentage of Time in Severe Pain and Pain Relief
Pain relief in the first 24 hours
|
9.93 percentage of time or relief
Standard Deviation 1.72
|
10.14 percentage of time or relief
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: at post operative day (POD) 14The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=47 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=46 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief
The percentage of time in severe pain on a scale of 0 - 10
|
14.47 percentage of time or relief
Standard Deviation 25.44
|
17.61 percentage of time or relief
Standard Deviation 28.3
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 14 / Percentage of Time in Severe Pain and Pain Relief
Pain relief in the first 24 hours on a scale of 0 - 10
|
9.65 percentage of time or relief
Standard Deviation 2.12
|
9.5 percentage of time or relief
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: at post operative day (POD) 90The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). All questions are scored on a scale of 0 to 10, with 0 meaning no pain/does not interfere/not at all and 10 meaning worst pain/completely interferes/extremely. A higher score means a worse outcome. This outcome records the percentage of time in severe pain and percentage pain relief, both scored from 0% to 100%.
Outcome measures
| Measure |
No PAI + ACB & IPACK
n=41 Participants
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=37 Participants
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief
The percentage of time in severe pain
|
9.02 percentage of time or relief
Standard Deviation 26.44
|
7.57 percentage of time or relief
Standard Deviation 23.5
|
|
PAIN OUT Questionnaire at Post Operative Day (POD) 90 / Percentage of Time in Severe Pain and Pain Relief
Pain relief in the first 24 hours
|
10.12 percentage of time or relief
Standard Deviation 2.63
|
10.37 percentage of time or relief
Standard Deviation 2.30
|
Adverse Events
No PAI + ACB & IPACK
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
PAI + ACB & IPACK
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No PAI + ACB & IPACK
n=47 participants at risk
Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)
Saline Control Periarticular Injection (PAI): equal volume of saline will be used in place of analgesics used in PAI injections
|
PAI + ACB & IPACK
n=47 participants at risk
Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine
Periarticular Injection (PAI): PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
|
|---|---|---|
|
Surgical and medical procedures
leakage at the incision site
|
0.00%
0/47 • Adverse event data were collected from subject enrollment through completion of data collection (3 months after surgery).
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected from subject enrollment through completion of data collection (3 months after surgery).
|
|
Cardiac disorders
postoperative myocardial infarction
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected from subject enrollment through completion of data collection (3 months after surgery).
|
0.00%
0/47 • Adverse event data were collected from subject enrollment through completion of data collection (3 months after surgery).
|
|
Surgical and medical procedures
postoperative reduced range of motion
|
0.00%
0/47 • Adverse event data were collected from subject enrollment through completion of data collection (3 months after surgery).
|
2.1%
1/47 • Number of events 1 • Adverse event data were collected from subject enrollment through completion of data collection (3 months after surgery).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place