Trial Outcomes & Findings for 4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans (NCT NCT02891798)
NCT ID: NCT02891798
Last Updated: 2022-01-14
Results Overview
SF-MPQ version 2 total score difference of Post-Operative Day 1 value minus the Baseline value. Differences can range from -10 to +10. Negative scores indicate a decrease in pain.
COMPLETED
PHASE3
98 participants
Baseline, Post-Operative day after surgery (7AM-9AM EST)
2022-01-14
Participant Flow
Participants were enrolled from November 2016 to October 2018 after HIPAA-compliant contact of the study recruiter by either the preoperative clinic or the orthopedic clinic clinical staff. Of the 571 screened, 473 were not eligible due to failing study inclusion/exclusion criteria (N=151), programmatic reasons (N=145), or not willing to participate (N=177), resulting in 98 patients enrolled in the study. Twenty of these were early terminations, leaving 78.
Study temporarily on-hold (6), Failed screening (3), Failed spinal (2), No study staff available (2), Surgery deferred (2), Current participation in another clinical trial (1), Intra-operative peri-prosthetic fracture (1), Patient chose another hospital (1), Surgery cancelled due to profuse vomiting after spinal anesthesia (1), and Uni-compartmental knee arthroplasty instead of total knee (1).
Participant milestones
| Measure |
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)
Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)
Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee and hip replacements
|
Bupivacaine Only (Control Arm)
Patients will receive a nerve block consisting of bupivacaine only.
Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee and hip replacements
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
16
|
|
Overall Study
COMPLETED
|
62
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans
Baseline characteristics by cohort
| Measure |
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)
n=62 Participants
Patients will receive a nerve blocks consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)
Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee and Hip replacements.
|
Bupivacaine Only (Control Arm)
n=16 Participants
Patients will receive a nerve block consisting of bupivacaine only.
Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee and Hip replacements.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 7.4 • n=39 Participants
|
65.6 years
STANDARD_DEVIATION 7.6 • n=41 Participants
|
66 years
STANDARD_DEVIATION 7.5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
69 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
53 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
68 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
African American
|
8 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
62 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
78 Participants
n=35 Participants
|
|
BMI (kg/m^2)
|
32.6 kg/m^2
STANDARD_DEVIATION 4.6 • n=39 Participants
|
31.9 kg/m^2
STANDARD_DEVIATION 5.1 • n=41 Participants
|
32 kg/m^2
STANDARD_DEVIATION 5 • n=35 Participants
|
|
Diabetes
|
23 participants
n=39 Participants
|
6 participants
n=41 Participants
|
29 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post-Operative day after surgery (7AM-9AM EST)Population: All participants who completed the protocol.
SF-MPQ version 2 total score difference of Post-Operative Day 1 value minus the Baseline value. Differences can range from -10 to +10. Negative scores indicate a decrease in pain.
Outcome measures
| Measure |
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)
n=62 Participants
Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)
Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
Bupivacaine Only (Control Arm)
n=16 Participants
Patients will receive a nerve block consisting of bupivacaine only.
Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
|---|---|---|
|
Short-Form McGill Pain Questionnaire (Version 2) Total Score Difference From Baseline
|
-1.85 score on a scale
Standard Deviation 2.04
|
-0.05 score on a scale
Standard Deviation 2.38
|
PRIMARY outcome
Timeframe: Baseline, Post-Operative day after surgery (7AM-9AM EST)Population: All participants who completed the protocol.
Continuous pain subscore difference of Post-Operative Day 1 value minus the Baseline value. Differences can range from -10 to +10. Negative scores indicate a decrease in pain.
Outcome measures
| Measure |
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)
n=62 Participants
Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)
Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
Bupivacaine Only (Control Arm)
n=16 Participants
Patients will receive a nerve block consisting of bupivacaine only.
Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
|---|---|---|
|
SF-MPQ2 Continuous Pain Subscore Difference From Baseline
|
-2.29 units on a scale
Standard Deviation 2.43
|
0.33 units on a scale
Standard Deviation 2.76
|
PRIMARY outcome
Timeframe: Baseline, Post-Operative day after surgery (7AM-9AM EST)Population: All participants who completed the protocol.
Intermittent pain subscore difference of Post-Operative Day 1 value minus the Baseline value. Differences can range from -10 to +10. Negative scores indicate a decrease in pain.
Outcome measures
| Measure |
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)
n=62 Participants
Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)
Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
Bupivacaine Only (Control Arm)
n=16 Participants
Patients will receive a nerve block consisting of bupivacaine only.
Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
|---|---|---|
|
SF-MPQ2 Intermittent Pain Subscore Difference From Baseline
|
-2.79 units on a scale
Standard Deviation 2.66
|
-1.14 units on a scale
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: Day after surgery (7AM-9AM EST)Population: All participants who completed the protocol. There was missing data for one participant in the Bupivacaine Only arm.
Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery.
Outcome measures
| Measure |
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)
n=62 Participants
Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)
Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
Bupivacaine Only (Control Arm)
n=15 Participants
Patients will receive a nerve block consisting of bupivacaine only.
Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
|---|---|---|
|
Quality of Recovery 15 Item Scale (QoR-15) Total Score
|
106.08 score on a scale
Standard Deviation 19.76
|
90.13 score on a scale
Standard Deviation 24.15
|
SECONDARY outcome
Timeframe: 6 weeks post-operationPopulation: All participants who completed the protocol. There was missing data for one participant in the Bupivacaine + BCD arm.
Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery.
Outcome measures
| Measure |
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)
n=61 Participants
Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)
Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
Bupivacaine Only (Control Arm)
n=16 Participants
Patients will receive a nerve block consisting of bupivacaine only.
Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
|---|---|---|
|
Quality of Recovery 15 Item Scale (QoR-15) Total Score
|
128.89 score on a scale
Standard Deviation 24.26
|
130.06 score on a scale
Standard Deviation 21.75
|
SECONDARY outcome
Timeframe: 6 weeks post-operationPopulation: All participants who completed the protocol. There was missing data for four participants in the Bupivacaine + BCD arm.
The Standing Balance Test score based on the ability of the participant to perform a series of standing exercises. Scores range from 0 to 4, with 4 indicating a longer time holding the stand (a better outcome). This test is germane to subjects with total joint replacement that are easily performed in the clinical settings. The test will capture the domains of muscle strength and activation, and balance.
Outcome measures
| Measure |
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)
n=58 Participants
Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)
Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
Bupivacaine Only (Control Arm)
n=16 Participants
Patients will receive a nerve block consisting of bupivacaine only.
Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
|---|---|---|
|
Performed-based Physical Function is Assessed Using the Standing Balance Test.
|
3.86 score on a scale
Standard Deviation 0.44
|
3.94 score on a scale
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: 6 weeks post-operationPopulation: All of the participants who completed the protocol. There was missing data for four participants in the Bupivacaine + BCD arm.
The Self-Selected Gait Speed Test is a timed test based on the ability of the participant to walk a 4 meter distance. This test is germane to subjects with total joint replacement that are easily performed in the clinical settings. The test captures the ability to walk.
Outcome measures
| Measure |
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)
n=58 Participants
Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)
Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
Bupivacaine Only (Control Arm)
n=16 Participants
Patients will receive a nerve block consisting of bupivacaine only.
Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
|---|---|---|
|
Performed-based Physical Function is Assessed Using the Self-Selected Gait Speed Test.
|
0.88 meters per second
Standard Deviation 0.20
|
0.94 meters per second
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: 6 weeks post-operationPopulation: All participants who completed the protocol. There was missing data for five participants in the Bupivacaine + BCD arm.
The Repeated Chair Stand Test is a timed test based on the ability of the participant to perform a series of standing exercises. This test is germane to subjects with total joint replacement that are easily performed in the clinical settings. The test will capture the domains of muscle strength and activation, and balance.
Outcome measures
| Measure |
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)
n=57 Participants
Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)
Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
Bupivacaine Only (Control Arm)
n=16 Participants
Patients will receive a nerve block consisting of bupivacaine only.
Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
|---|---|---|
|
Performed-based Physical Function is Assessed Using the Repeated Chair Stand Test.
|
12.34 seconds
Standard Deviation 4.31
|
11.93 seconds
Standard Deviation 2.09
|
Adverse Events
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)
Bupivacaine Only (Control Arm)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)
n=62 participants at risk
Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD)
Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
Bupivacaine Only (Control Arm)
n=16 participants at risk
Patients will receive a nerve block consisting of bupivacaine only.
Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Foot drop
|
1.6%
1/62 • Number of events 1 • Throughout hospitalization, and at 2-week and 6-week postoperative visits.
Adverse events reported here only include those that were unexpected in the normal course of surgery/anesthesia.
|
0.00%
0/16 • Throughout hospitalization, and at 2-week and 6-week postoperative visits.
Adverse events reported here only include those that were unexpected in the normal course of surgery/anesthesia.
|
Additional Information
Brian A. Williams, MD, MBA
VA Pittsburgh Health System, and University of Pittsburgh
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place