Clinical trial NCT02891798: 4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans
Official title: 4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: analgesia,
buprenorphine
clonidine
dexamethasone
bupivacaine
nerve block
Lead sponsor: VA Pittsburgh Healthcare System
Sponsor class: FED
Collaborators: name: University of Pittsburgh
First posted: 2016-09-08
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Short-Form McGill Pain Questionnaire (Version 2) Total Score Difference From Baseline
timeFrame: Baseline, Post-Operative day after surgery (7AM-9AM EST)
measure: SF-MPQ2 Continuous Pain Subscore Difference From Baseline
timeFrame: Baseline, Post-Operative day after surgery (7AM-9AM EST)
measure: SF-MPQ2 Intermittent Pain Subscore Difference From Baseline
timeFrame: Baseline, Post-Operative day after surgery (7AM-9AM EST)
Secondary outcomes:
measure: Quality of Recovery 15 Item Scale (QoR-15) Total Score
timeFrame: Day after surgery (7AM-9AM EST)
measure: Quality of Recovery 15 Item Scale (QoR-15) Total Score
timeFrame: 6 weeks post-operation
measure: Performed-based Physical Function is Assessed Using the Standing Balance Test.
timeFrame: 6 weeks post-operation
measure: Performed-based Physical Function is Assessed Using the Self-Selected Gait Speed Test.
timeFrame: 6 weeks post-operation
measure: Performed-based Physical Function is Assessed Using the Repeated Chair Stand Test.
timeFrame: 6 weeks post-operation
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System
name: Brian Williams, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams 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.