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

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ClinicalTrials.gov Identifier: NCT02891798
Recruitment Status : Recruiting
First Posted : September 8, 2016
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Brian Williams, VA Pittsburgh Healthcare System

Tracking Information
First Submitted Date  ICMJE August 12, 2016
First Posted Date  ICMJE September 8, 2016
Last Update Posted Date May 14, 2019
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
Short-Form McGill Pain Questionnaire (version 2) [ Time Frame: 24 hours post surgery ]
SF-MPQ version 2
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02891798 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
  • Performed-based physical function is assessed using timed tests such as the 'standing balance test', the 'self-selected gait speed test', and the 'repeated chair stand test' [ Time Frame: Post-op days 1-5 and 6 weeks post-op ]
    These tests are germane to subjects with total joint replacement that are easily performed in the clinical settings. The tests will capture the domains of muscle strength and activation, balance, and ability to walk.
  • Anesthesia-related symptoms [ Time Frame: Post-op days 1-5, 2 weeks post-op and 6 weeks post-op ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans
Official Title  ICMJE 4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • 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 Name: "Marcaine" + CBD (clonidine, buprenorphine, dexamethasone)
  • 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 Name: Marcaine
Study Arms  ICMJE
  • Experimental: Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)
    Patients will receive a nerve block consisting of bupivacaine plus clonidine-buprenorphine-dexamethasone (Bupivacaine-CBD)
    Intervention: Drug: Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)
  • Active Comparator: Bupivacaine Only (control arm)
    Patients will receive a nerve block consisting of bupivacaine only.
    Intervention: Drug: Bupivacaine Only (control arm)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen Gilbert 412-360-6666 karen.gilbert2@va.gov
Contact: Samantha Bonant, MS, CCRP 412-360-3788 samantha.bonant@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02891798
Other Study ID Numbers  ICMJE PRO 1357
13232002 ( Other Identifier: USARMC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brian Williams, VA Pittsburgh Healthcare System
Study Sponsor  ICMJE Brian Williams
Collaborators  ICMJE University of Pittsburgh
Investigators  ICMJE
Principal Investigator: Brian Williams, MD, MBA VA Pittsburgh Healthcare System
PRS Account VA Pittsburgh Healthcare System
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP