NCT04047446已完成4 期
Prolonging the Interscalene Brachial Plexus Block by Adding Liposomal Bupivacaine or Preservative Free Dexamethasone to Bupivacaine: a Non-inferiority Trial
Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2019年7月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours
研究概览
简要总结
In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •Age 18 years or older
- •Scheduled for elective outpatient arthroscopic shoulder surgery
排除标准
- •History of allergy to local anesthetic, or one of the study medications
- •Pre-existing neurological deficits
- •Psychiatric or cognitive disorders that prohibit patients from following study protocol
- •History of drug or alcohol abuse
- •Chronic opioid use (longer than 3 months)
- •Chronic pain syndromes
- •Infection at the site of injection
- •Patients with severe pulmonary disease
- •Herniated cervical disc, cervical myelopathy
- •Contraindication for general anesthesia and/or interscalene nerve block
- •Pregnancy
- •Open shoulder arthrotomies.
- •Non English speakers
研究组 & 干预措施
Liposomal bupivacaine & standard bupivacaine
Experimental
干预措施: Exparel 133 MG Per 10 ML Injection (Drug)
Standard bupivacaine & dexamethasone
Active Comparator
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours
时间窗: First 72 hours pain
NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome.
次要结局
- Numerical Rating Scale (NRS) Pain at Rest(Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7)
- Numerical Rating Scale (NRS) Pain With Movement(Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7)
- Opioid Consumption(Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7)
- Patient Satisfaction With Pain Management: Scale(Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7)
- Motor Block Resolution(24, 48, 72, 96 (if needed) hours postoperatively)
- Time to Readiness for Discharge(Postanesthesia care unit (0-6 hours postoperative))
- Postanesthesia Care Unit Length of Stay(Postanesthesia care unit (0-6 hours postoperative))
- Brief Pain Inventory Short-form(Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7)
- Duration of Analgesic Block(24, 48, 72, 96 (if needed) hours postoperatively)
- Sensory Resolution(24, 48, 72, 96 (if needed) hours postoperatively)
研究者
研究点 (1)
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