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

January 5, 2022 updated by: Brian Williams
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-Form McGill Pain Questionnaire (Version 2) Total Score Difference From Baseline
Time Frame: 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.
Baseline, Post-Operative day after surgery (7AM-9AM EST)
SF-MPQ2 Continuous Pain Subscore Difference From Baseline
Time Frame: 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.
Baseline, Post-Operative day after surgery (7AM-9AM EST)
SF-MPQ2 Intermittent Pain Subscore Difference From Baseline
Time Frame: 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.
Baseline, Post-Operative day after surgery (7AM-9AM EST)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery 15 Item Scale (QoR-15) Total Score
Time Frame: Day after surgery (7AM-9AM EST)
Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery.
Day after surgery (7AM-9AM EST)
Quality of Recovery 15 Item Scale (QoR-15) Total Score
Time Frame: 6 weeks post-operation
Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery.
6 weeks post-operation
Performed-based Physical Function is Assessed Using the Standing Balance Test.
Time Frame: 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.
6 weeks post-operation
Performed-based Physical Function is Assessed Using the Self-Selected Gait Speed Test.
Time Frame: 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.
6 weeks post-operation
Performed-based Physical Function is Assessed Using the Repeated Chair Stand Test.
Time Frame: 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.
6 weeks post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brian Williams

Collaborators

University of Pittsburgh

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ACTUAL)

July 12, 2021

Study Completion (ACTUAL)

August 20, 2021

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (ESTIMATE)

September 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO 1357
  • 13232002 (OTHER: USARMC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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