NCT03887650已完成4 期
LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total Opioid Consumption
研究概览
简要总结
This will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and PF dexamethasone in patients undergoing primary shoulder arthroplasty. Primary endpoint will be total opioid consumption in the first three post-operative days.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age >18 years;
- •Lack of language barrier;
- •Informed consent obtained;
- •Presenting for primary total shoulder arthroplasty (TSA), both anatomic and reverse, by a specialty-trained surgeon;
- •American Society of Anesthesiology (ASA) physical status score I- III
排除标准
- •Presence of a language barrier;
- •Inability to complete telephone and/or paper questionnaire;
- •Lack of consent;
- •Allergy to local anesthetic;
- •Chronic pain syndrome and/or preoperative opioid use > 50 MME per day (including extended-release formulations and methadone);
- •Preoperative consultation to chronic pain service;
- •History of (<3 months) or current substance abuse, including any illicit drugs or excessive alcohol consumption as defined by the Office of Disease Prevention and Health Promotion (4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men);
- •Baseline peripheral neuropathy of the brachial plexus;
- •Contraindication to receiving single shot peripheral nerve blockade; including antithrombotic medications as per most recent American Society of Regional - - -Anesthesiology (ASRA) guidelines 17 , coagulopathy or coagulation disorder, or infection at injection site;
- •Severe chronic obstructive pulmonary disease (COPD) or other significant pulmonary disease where interscalene nerve block would be contraindicated due to concern for respiratory failure from phrenic nerve palsy;
- •Weight < 45 kg, given concern for local anesthetic toxicity at dosages given for the study; ASA score IV-V;
- •Revision arthroplasty;
- •Anatomic abnormality that limits or prevents the patient from receiving an interscalene nerve block;
- •Pregnant, nursing, or planning to become pregnant during the study or within 1 month after the shoulder replacement surgery
研究组 & 干预措施
Liposomal Bupivacaine 1.3%
Experimental
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
干预措施: Liposomal Bupivicaine 1.3% (Drug)
Bupivacaine 0.5% with Adjuncts
Active Comparator
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
干预措施: Bupivacaine 0.5% (Drug)
结局指标
主要结局
Total Opioid Consumption
时间窗: Up to 120 postoperative hours
Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)
次要结局
- Time to First Opioid Medication(from the time of the block injection until discharge, assessed up to 72 postoperative hours.)
- Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours(24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60)
- Hospital Length-of-stay(From the date of admission until discharge, assessed up to 72 hours.)
- Assessment of Patient Overall Satisfaction With Pain Control(POD4 - 60 days)
- Incidence of Distress From Block Numbness(At PACU and Postoperative day 2)
- Duration of Sensory Nerve Block(Day 1, after Day 1 (day 2 to 60), and at postoperative day 60)
- Day of the Final Opioids Used(0-96 postoperative hours)
- Motor Recovery(PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.)
研究者
Kevin Finkel
Principal Investigator
Hartford Hospital
研究点 (1)
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