4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans
2 other identifiers
interventional
98
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 pain
Started Oct 2016
Longer than P75 for phase_3 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2021
CompletedResults Posted
Study results publicly available
December 20, 2021
CompletedJanuary 14, 2022
January 1, 2022
4.8 years
August 12, 2016
October 13, 2021
January 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Short-Form McGill Pain Questionnaire (Version 2) Total Score Difference From Baseline
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
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
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 Outcomes (5)
Quality of Recovery 15 Item Scale (QoR-15) Total Score
Day after surgery (7AM-9AM EST)
Quality of Recovery 15 Item Scale (QoR-15) Total Score
6 weeks post-operation
Performed-based Physical Function is Assessed Using the Standing Balance Test.
6 weeks post-operation
Performed-based Physical Function is Assessed Using the Self-Selected Gait Speed Test.
6 weeks post-operation
Performed-based Physical Function is Assessed Using the Repeated Chair Stand Test.
6 weeks post-operation
Study Arms (2)
Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)
EXPERIMENTALPatients will receive a nerve block consisting of bupivacaine plus clonidine-buprenorphine-dexamethasone (Bupivacaine-CBD)
Bupivacaine Only (control arm)
ACTIVE COMPARATORPatients will receive a nerve block consisting of bupivacaine only.
Interventions
Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements
Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brian Williamslead
- University of Pittsburghcollaborator
Study Sites (1)
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Related Publications (2)
Aloziem OU, Williams BA, Mikolic JM, Boudreaux-Kelly MY, Faruque S, Piva SR, Ibinson JW, Switzer GE. Assessing Common Content and Responsiveness of the QoR-15 and the SF-8 in the Context of Recovery from Regional Anesthesia for Joint Replacement. Mil Med. 2023 Nov 3;188(11-12):e3469-e3476. doi: 10.1093/milmed/usad191.
PMID: 37256753DERIVEDWilliams BA, Ibinson JW, Mikolic JM, Boudreaux-Kelly MY, Paiste HJ, Gilbert KL, Bonant SA, Ritter ME, Ezaru CS, Muluk VS, Piva SR. Day-One Pain Reductions After Hip and Knee Replacement When Buprenorphine-Clonidine-Dexamethasone Is Added to Bupivacaine Nerve/Plexus Blocks: A Randomized Clinical Trial. Pain Med. 2022 Jan 3;23(1):57-66. doi: 10.1093/pm/pnab325.
PMID: 34730810DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and 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.
Results Point of Contact
- Title
- Brian A. Williams, MD, MBA
- Organization
- VA Pittsburgh Health System, and University of Pittsburgh
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Williams, MD, MBA
VA Pittsburgh Healthcare System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- VAPHS Surgical Specialties Service Line Medical Director
Study Record Dates
First Submitted
August 12, 2016
First Posted
September 8, 2016
Study Start
October 1, 2016
Primary Completion
July 12, 2021
Study Completion
August 20, 2021
Last Updated
January 14, 2022
Results First Posted
December 20, 2021
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share