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Completed

NCT Number: NCT02891798

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

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).

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 85, and undergoing a total knee or hip replacement.
  • Fluent in English, decision competent, willing and able to provide written informed consent, and able to complete the study's schedule of assessments.
  • Able to walk >3m without an assisting device.
  • Have a BMI ≤ 40 kg/m2.

Exclusion criteria

  • Current participation in another orthopedic/Physical Therapy/rehab/anesthesiology interventional clinical trial.
  • Are at significant behavioral risks or have refractory major psychiatric disorders.
  • Revision surgery on the same extremity.
  • Have an American Surgical Association (ASA) Physical Status classification of 4 or higher.
  • Have been diagnosed with clinically significant neuropathy with its origins in either diabetes or other causes; have neuromuscular disease that would influence data collection.
  • Have a surgically-fused lumbar spine, or a spinal cord simulator, or other condition that would contraindicate or prohibit the conduct of spinal anesthesia.
  • 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.
  • Are undergoing Total Knee Arthroplasty (TKA)/Total Hip Arthroplasty (THA) for a tumor.
  • Have contraindications (e.g., anaphylaxis) to any of the study drugs.
  • Have a systemic fungal infection.
  • Have a known hypersensitivity to bupivacaine hydrochloride or to any local anesthetic of the amide-type or to other components of bupivacaine hydrochloride solutions.
  • Have a known or suspected buprenorphine hypersensitivity (not including nausea and/or vomiting).
  • Have a gastro-intestinal (GI) obstruction.
  • Have paralytic ileus.
  • Pregnant women
  • 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.

Treatment and study plan

Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)

Drug

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)

Bupivacaine Only (control arm)

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Brian Williams

Fed

Collaborators

  • University of Pittsburgh

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 8, 2016
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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