4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans
Condition: Pain
Intervention: Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone); Bupivacaine Only (control arm)
Intervention description: 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
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Clonidine; Buprenorphine; Bupivacaine; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: analgesia,; buprenorphine; clonidine; dexamethasone; bupivacaine; nerve block

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).
    

Eligibility criteria:

        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.