4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Short-Form McGill Pain Questionnaire (Version 2) Total Score Difference From Baseline
研究概览
简要总结
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).
详细描述
Patients will have spinal anesthesia for their hip or knee replacement surgery. They will also receive the nerve blocks described above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)
Patients will receive a nerve block consisting of bupivacaine plus clonidine-buprenorphine-dexamethasone (Bupivacaine-CBD)
干预措施: Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone) (Drug)
Bupivacaine Only (control arm)
Patients will receive a nerve block consisting of bupivacaine only.
干预措施: Bupivacaine Only (control arm) (Drug)
结局指标
主要结局
Short-Form McGill Pain Questionnaire (Version 2) Total Score Difference From Baseline
时间窗: 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.
SF-MPQ2 Continuous Pain Subscore Difference From Baseline
时间窗: 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.
SF-MPQ2 Intermittent Pain Subscore Difference From Baseline
时间窗: 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.
次要结局
- Performed-based Physical Function is Assessed Using the Standing Balance Test.(6 weeks post-operation)
- Quality of Recovery 15 Item Scale (QoR-15) Total Score(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)
研究者
Brian Williams
VAPHS Surgical Specialties Service Line Medical Director
VA Pittsburgh Healthcare System