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临床试验/NCT05068960
NCT05068960已完成4 期

A Prospective Randomized Controlled Trial to Evaluate the Efficacy of an Interscalene Brachial Plexus Block and Multimodal Analgesia with and Without Liposomal Bupivacaine for Postoperative Pain Control in Total Shoulder Arthroplasty

Scripps Clinic1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月1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
入组人数
100
试验地点
1
主要终点
Narcotic usage

研究概览

简要总结

A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.

详细描述

In order to reduce narcotic abuse potential, orthopaedic surgeons have explored multimodal pain regimens in addition to regional anesthesia to improve postoperative pain control. One commonly used intervention to reduce postoperative shoulder pain has been the interscalene brachial plexus block. This block provides significant pain relief for shoulder procedures, but has been limited to less than 24 hours even with long acting anesthetics. In the setting of shoulder arthroplasty, this short-term pain control often leads to the need for increased narcotic pain medication. Since shoulder arthroplasty has been steadily increasing in the United States with an annual growth rate of 10.6%, it is imperative to control patients' postoperative pain without increasing their risk for opiate abuse. A potential method for achieving this is by using liposomal bupivacaine in the interscalene blocks.

This study is a double blind, prospective, randomized trial to evaluate the postoperative pain profiles among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine. The purpose of this study is to determine if patients undergoing shoulder arthroplasty with an interscalene brachial plexus block with liposomal bupivacaine (study group) or without liposomal bupivacaine (control group) will have differences in postoperative opiate consumption, patient-reported pain, satisfaction with surgery, and shoulder function.

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)

盲法说明

Patients will be blinded. Surgeon, nurses, and other clinical care providers will be blinded. Research staff will be blinded. The only staff who knows study group assignment is the pharmacist and the anesthesiologist and preoperative nurse who will administer the interscalene block.

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty

排除标准

  • Patients under the age of 50 years
  • Patients over the age of 85
  • Patients undergoing a revision shoulder procedure
  • Documented drug or alcohol abuse
  • Active narcotic use within 3 months prior to surgery
  • Neurological deficit
  • Allergy to amide anesthetics
  • Oxycodone intolerance
  • Unable to take Celebrex
  • Enrollment in another clinical trial
  • Comorbidity that is contraindicated with the administration of an interscalene block
  • Cognitive or mental health status that interferes with study

研究组 & 干预措施

Study group

Experimental

The study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine [133mg].

干预措施: Liposomal bupivacaine (Drug)

Study group

Experimental

The study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine [133mg].

干预措施: Bupivacaine (Drug)

Control group

Active Comparator

The control group will receive an interscalene block consisting of 20 mL of 0.5%bupivacaine alone.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Narcotic usage

时间窗: Postoperatively (up to 1 week)

Number and type of narcotic pain pills consumed during the first postoperative week (also converted into morphine equivalents)

次要结局

  • Severity of pain and its impact on functioning (Brief Pain Inventory - Short Form modified)(Postoperatively (at 1 week))
  • Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively(Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively)
  • Satisfaction with the results of surgery (Self-Administered Patient Satisfaction Scale)(Postoperatively (at 4 weeks))
  • American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively(Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively)
  • Non narcotic pain medication usage(Postoperatively (up to 1 week))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heinz Hoenecke, MD

Principal Investigator

Scripps Clinic

研究点 (1)

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