4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans

Sponsor
Brian Williams (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02891798
Collaborator
University of Pittsburgh (Other)
98
Enrollment
1
Location
2
Arms
58.6
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

After total joint replacement, early hospital discharge to home (with patients capable of continuing a home-based rehabilitation program) is a cost- effective management strategy. This project will use improved local anesthetic nerve block techniques to enhance technical capability and clinical practice by (i) reducing pain and other morbidities during recovery, (ii) improving weight-bearing achievement during in-hospital physical therapy to allow for earlier return home, and (iii) continued rehabilitation as an outpatient at home when feasible (versus in an extended care facility).

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)
  • Drug: Bupivacaine Only (control arm)
Phase 3

Detailed Description

Patients will have spinal anesthesia for their hip or knee replacement surgery. They will also receive the nerve blocks described above

Study Design

Study Type:
Interventional
Actual Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans
Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Jul 12, 2021
Actual Study Completion Date :
Aug 20, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)

Patients will receive a nerve block consisting of bupivacaine plus clonidine-buprenorphine-dexamethasone (Bupivacaine-CBD)

Drug: Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)
Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements
Other Names:
  • "Marcaine" + CBD (clonidine, buprenorphine, dexamethasone)
  • Active Comparator: Bupivacaine Only (control arm)

    Patients will receive a nerve block consisting of bupivacaine only.

    Drug: Bupivacaine Only (control arm)
    Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements
    Other Names:
  • Marcaine
  • Outcome Measures

    Primary Outcome Measures

    1. Short-Form McGill Pain Questionnaire (Version 2) Total Score Difference From Baseline [Baseline, Post-Operative day after surgery (7AM-9AM EST)]

      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.

    2. SF-MPQ2 Continuous Pain Subscore Difference From Baseline [Baseline, Post-Operative day after surgery (7AM-9AM EST)]

      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.

    3. SF-MPQ2 Intermittent Pain Subscore Difference From Baseline [Baseline, Post-Operative day after surgery (7AM-9AM EST)]

      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.

    Secondary Outcome Measures

    1. Quality of Recovery 15 Item Scale (QoR-15) Total Score [Day after surgery (7AM-9AM EST)]

      Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery.

    2. Quality of Recovery 15 Item Scale (QoR-15) Total Score [6 weeks post-operation]

      Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery.

    3. Performed-based Physical Function is Assessed Using the Standing Balance Test. [6 weeks post-operation]

      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.

    4. Performed-based Physical Function is Assessed Using the Self-Selected Gait Speed Test. [6 weeks post-operation]

      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.

    5. Performed-based Physical Function is Assessed Using the Repeated Chair Stand Test. [6 weeks post-operation]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Age between 18 and 85, and undergoing a total knee or hip replacement.

    2. Fluent in English, decision competent, willing and able to provide written informed consent, and able to complete the study's schedule of assessments.

    3. Able to walk >3m without an assisting device.

    4. Have a BMI ≤ 40 kg/m2.

    Exclusion Criteria:
    1. Current participation in another orthopedic/Physical Therapy/rehab/anesthesiology interventional clinical trial.

    2. Are at significant behavioral risks or have refractory major psychiatric disorders.

    3. Revision surgery on the same extremity.

    4. Have an American Surgical Association (ASA) Physical Status classification of 4 or higher.

    5. Have been diagnosed with clinically significant neuropathy with its origins in either diabetes or other causes; have neuromuscular disease that would influence data collection.

    6. Have a surgically-fused lumbar spine, or a spinal cord simulator, or other condition that would contraindicate or prohibit the conduct of spinal anesthesia.

    7. At significant risk for postoperative substance abuse, or immediate-postoperative substance abuse withdrawal symptoms (alcohol, cocaine, enrolled in methadone or buprenorphine opioid withdrawal programs, etc.) Previous or current use of marijuana will not be an exclusion for study enrollment.

    8. Are undergoing Total Knee Arthroplasty (TKA)/Total Hip Arthroplasty (THA) for a tumor.

    9. Have contraindications (e.g., anaphylaxis) to any of the study drugs.

    10. Have a systemic fungal infection.

    11. Have a known hypersensitivity to bupivacaine hydrochloride or to any local anesthetic of the amide-type or to other components of bupivacaine hydrochloride solutions.

    12. Have a known or suspected buprenorphine hypersensitivity (not including nausea and/or vomiting).

    13. Have a gastro-intestinal (GI) obstruction.

    14. Have paralytic ileus.

    15. Pregnant women

    16. Have had a kidney or liver transplant.

    Veterans will not be excluded from participation based on smoking status, diagnosis of obstructive sleep apnea, or baseline monitored consumption of therapeutic opioids for documented medical indications; instead, these variables will be codified and quantified for subsequent covariate statistical analysis.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1VA Pittsburgh Healthcare SystemPittsburghPennsylvaniaUnited States15240

    Sponsors and Collaborators

    • Brian Williams
    • University of Pittsburgh

    Investigators

    • Principal Investigator: Brian Williams, MD, MBA, VA Pittsburgh Healthcare System

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Brian Williams, VAPHS Surgical Specialties Service Line Medical Director, VA Pittsburgh Healthcare System
    ClinicalTrials.gov Identifier:
    NCT02891798
    Other Study ID Numbers:
    • PRO 1357
    • 13232002
    First Posted:
    Sep 8, 2016
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Brian Williams, VAPHS Surgical Specialties Service Line Medical Director, VA Pittsburgh Healthcare System
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsParticipants 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.
    Pre-assignment DetailStudy 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).
    Arm/Group TitleBupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Arm/Group DescriptionPatients 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 replacementsPatients 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
    Period Title: Overall Study
    STARTED6216
    COMPLETED6216
    NOT COMPLETED00

    Baseline Characteristics

    Arm/Group TitleBupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)Total
    Arm/Group DescriptionPatients 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.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 of all reporting groups
    Overall Participants621678
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    66.7
    (7.4)
    65.6
    (7.6)
    66
    (7.5)
    Sex: Female, Male (Count of Participants)
    Female
    6
    9.7%
    3
    18.8%
    9
    11.5%
    Male
    56
    90.3%
    13
    81.3%
    69
    88.5%
    Race/Ethnicity, Customized (Count of Participants)
    Caucasian
    53
    85.5%
    15
    93.8%
    68
    87.2%
    African American
    8
    12.9%
    1
    6.3%
    9
    11.5%
    Other
    1
    1.6%
    0
    0%
    1
    1.3%
    Hispanic
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    62
    100%
    16
    100%
    78
    100%
    BMI (kg/m^2) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    32.6
    (4.6)
    31.9
    (5.1)
    32
    (5)
    Diabetes (participants) [Number]
    Number [participants]
    23
    37.1%
    6
    37.5%
    29
    37.2%

    Outcome Measures

    1. Primary Outcome
    TitleShort-Form McGill Pain Questionnaire (Version 2) Total Score Difference From Baseline
    DescriptionSF-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.
    Time FrameBaseline, Post-Operative day after surgery (7AM-9AM EST)

    Outcome Measure Data

    Analysis Population Description
    All participants who completed the protocol.
    Arm/Group TitleBupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Arm/Group DescriptionPatients 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 replacementsPatients 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
    Measure Participants6216
    Mean (Standard Deviation) [score on a scale]
    -1.85
    (2.04)
    -0.05
    (2.38)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone), Bupivacaine Only (Control Arm)
    Comments Comparison of SF-MPQ2 Total Score Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.003
    Comments
    Methodt-test, 2 sided
    Comments
    2. Primary Outcome
    TitleSF-MPQ2 Continuous Pain Subscore Difference From Baseline
    DescriptionContinuous 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.
    Time FrameBaseline, Post-Operative day after surgery (7AM-9AM EST)

    Outcome Measure Data

    Analysis Population Description
    All participants who completed the protocol.
    Arm/Group TitleBupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Arm/Group DescriptionPatients 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 replacementsPatients 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
    Measure Participants6216
    Mean (Standard Deviation) [units on a scale]
    -2.29
    (2.43)
    0.33
    (2.76)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone), Bupivacaine Only (Control Arm)
    Comments Comparison of SF-MPQ2 Continuous Pain Subscore Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.001
    Comments
    Methodt-test, 2 sided
    Comments
    3. Primary Outcome
    TitleSF-MPQ2 Intermittent Pain Subscore Difference From Baseline
    DescriptionIntermittent 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.
    Time FrameBaseline, Post-Operative day after surgery (7AM-9AM EST)

    Outcome Measure Data

    Analysis Population Description
    All participants who completed the protocol.
    Arm/Group TitleBupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Arm/Group DescriptionPatients 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 replacementsPatients 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
    Measure Participants6216
    Mean (Standard Deviation) [units on a scale]
    -2.79
    (2.66)
    -1.14
    (3.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone), Bupivacaine Only (Control Arm)
    Comments Comparison of SF-MPQ2 Intermittent Pain Subscore Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.038
    Comments
    Methodt-test, 2 sided
    Comments
    4. Secondary Outcome
    TitleQuality of Recovery 15 Item Scale (QoR-15) Total Score
    DescriptionQuality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery.
    Time FrameDay after surgery (7AM-9AM EST)

    Outcome Measure Data

    Analysis Population Description
    All participants who completed the protocol. There was missing data for one participant in the Bupivacaine Only arm.
    Arm/Group TitleBupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Arm/Group DescriptionPatients 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 replacementsPatients 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
    Measure Participants6215
    Mean (Standard Deviation) [score on a scale]
    106.08
    (19.76)
    90.13
    (24.15)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone), Bupivacaine Only (Control Arm)
    Comments Comparison of QoR-15 Total Score at post-operative day 1 between the 4-drug nerve block group and the bupivacaine only group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.009
    Comments
    Methodt-test, 2 sided
    Comments
    5. Secondary Outcome
    TitleQuality of Recovery 15 Item Scale (QoR-15) Total Score
    DescriptionQuality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery.
    Time Frame6 weeks post-operation

    Outcome Measure Data

    Analysis Population Description
    All participants who completed the protocol. There was missing data for one participant in the Bupivacaine + BCD arm.
    Arm/Group TitleBupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Arm/Group DescriptionPatients 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 replacementsPatients 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
    Measure Participants6116
    Mean (Standard Deviation) [score on a scale]
    128.89
    (24.26)
    130.06
    (21.75)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone), Bupivacaine Only (Control Arm)
    Comments Comparison of QoR-15 Total Score at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group
    Type of Statistical Test Non-Inferiority
    Comments Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly lower score for the QoR-15 Total Score.
    Statistical Test of Hypothesisp-Value0.861
    Comments
    Methodt-test, 2 sided
    Comments
    6. Secondary Outcome
    TitlePerformed-based Physical Function is Assessed Using the Standing Balance Test.
    DescriptionThe 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.
    Time Frame6 weeks post-operation

    Outcome Measure Data

    Analysis Population Description
    All participants who completed the protocol. There was missing data for four participants in the Bupivacaine + BCD arm.
    Arm/Group TitleBupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Arm/Group DescriptionPatients 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 replacementsPatients 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
    Measure Participants5816
    Mean (Standard Deviation) [score on a scale]
    3.86
    (0.44)
    3.94
    (0.25)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone), Bupivacaine Only (Control Arm)
    Comments Comparison of Standing Balance Test score at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group
    Type of Statistical Test Non-Inferiority
    Comments Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly lower score for the Standing Balance test.
    Statistical Test of Hypothesisp-Value0.512
    Comments
    Methodt-test, 2 sided
    Comments
    7. Secondary Outcome
    TitlePerformed-based Physical Function is Assessed Using the Self-Selected Gait Speed Test.
    DescriptionThe 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.
    Time Frame6 weeks post-operation

    Outcome Measure Data

    Analysis Population Description
    All of the participants who completed the protocol. There was missing data for four participants in the Bupivacaine + BCD arm.
    Arm/Group TitleBupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Arm/Group DescriptionPatients 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 replacementsPatients 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
    Measure Participants5816
    Mean (Standard Deviation) [meters per second]
    0.88
    (0.20)
    0.94
    (0.21)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone), Bupivacaine Only (Control Arm)
    Comments Comparison of Self-Selected Gait Speed rate at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group.
    Type of Statistical Test Non-Inferiority
    Comments Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly slower rate for the Self-Selected Gait Speed test.
    Statistical Test of Hypothesisp-Value0.339
    Comments
    Methodt-test, 2 sided
    Comments
    8. Secondary Outcome
    TitlePerformed-based Physical Function is Assessed Using the Repeated Chair Stand Test.
    DescriptionThe 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.
    Time Frame6 weeks post-operation

    Outcome Measure Data

    Analysis Population Description
    All participants who completed the protocol. There was missing data for five participants in the Bupivacaine + BCD arm.
    Arm/Group TitleBupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Arm/Group DescriptionPatients 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 replacementsPatients 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
    Measure Participants5716
    Mean (Standard Deviation) [seconds]
    12.34
    (4.31)
    11.93
    (2.09)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone), Bupivacaine Only (Control Arm)
    Comments Comparison of Repeated Chair Stand time at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group.
    Type of Statistical Test Non-Inferiority
    Comments Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly slower time for the Repeated Chair Stand test.
    Statistical Test of Hypothesisp-Value0.711
    Comments
    Methodt-test, 2 sided
    Comments

    Adverse Events

    Time FrameThroughout hospitalization, and at 2-week and 6-week postoperative visits.
    Adverse Event Reporting Description Adverse events reported here only include those that were unexpected in the normal course of surgery/anesthesia.
    Arm/Group TitleBupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Arm/Group DescriptionPatients 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 replacementsPatients 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
    All Cause Mortality
    Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/62 (0%) 0/16 (0%)
    Serious Adverse Events
    Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/62 (0%) 0/16 (0%)
    Other (Not Including Serious) Adverse Events
    Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone)Bupivacaine Only (Control Arm)
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total1/62 (1.6%) 0/16 (0%)
    Musculoskeletal and connective tissue disorders
    Foot drop1/62 (1.6%) 10/16 (0%) 0

    Limitations/Caveats

    The sample size determined before the study began was N=100 patients to undergo primary THA and N=100 patients to undergo primary TKA, with these patients not undergoing physical therapy until day-one after surgery; these sample sizes were ultimately not achieved. By early 2018, same-day physical therapy (after surgery) became the new hospital guideline for patients undergoing primary THA and TKA, such that by mid-2018, the study was interrupted. Only the described 78 patients completed.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleBrian A. Williams, MD, MBA
    OrganizationVA Pittsburgh Health System, and University of Pittsburgh
    Phone412-360-1602
    Emailbrian.williams6@va.gov
    Responsible Party:
    Brian Williams, VAPHS Surgical Specialties Service Line Medical Director, VA Pittsburgh Healthcare System
    ClinicalTrials.gov Identifier:
    NCT02891798
    Other Study ID Numbers:
    • PRO 1357
    • 13232002
    First Posted:
    Sep 8, 2016
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Jan 1, 2022