Liposomal Bupivacaine vs. Interscalene Nerve Block for Pain Control After Total Shoulder Arthroplasty: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Visual Analog Scale Pain Score at 24 Hours Postoperatively
研究概览
简要总结
This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for pain control after total shoulder replacements. Each method will be assessed in terms of post operative pain scores, pain medication consumption, length of stay, complications (nerve injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The aims of this study will be achieved through a randomized controlled trial and cost-effectiveness analysis.
详细描述
After the decision to proceed with shoulder replacement surgery, patients will be asked to participate in this randomized trial. Consent will be completed after explanation of each treatment group and the data to be collected. Patients will be randomized into one of the two treatment groups by simple randomization into one of two groups: Group 1 will receive interscalene nerve block and group 2 will receive liposomal bupivacaine for postoperative analgesia. Randomization will be stratified by site.
The surgeon at each site will be trained prior to enrollment on the correct way to perform Exparel injections intraoperatively. Patients in the interscalene nerve block group will be given a single shot block in the preoperative area by a fellowship-trained anesthesiologist.
The primary outcome is pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain). Secondary outcomes are postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 hours; VAS pain score at the first postoperative visit ; intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1); duration of stay in the post-anesthesia care unit (PACU); duration of hospital stay; and VAS score for satisfaction with pain control in the hospital and at home, assessed at participants' first postoperative visit. VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Degenerative changes of the shoulder joint (documented by radiographs) in patients planning total joint replacement with one of the study's four fellowship-trained orthopaedic surgeons.
- •Patients who require revision surgeries, hemiarthroplasties, or who have chronic pain issues will be included.
排除标准
- •Allergy to liposomal bupivacaine
- •Contraindications to the interscalene nerve block such as:
- •Preexisting neurologic defects
- •Local anesthetic allergy
- •Coagulopathy
- •Contralateral phrenic nerve dysfunction
- •Severe chronic obstructive pulmonary disease
研究组 & 干预措施
Interscalene Nerve Block
Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
干预措施: Interscalene Nerve Block (Drug)
Liposomal Bupivacaine
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Visual Analog Scale Pain Score at 24 Hours Postoperatively
时间窗: At 24 hours after surgery
The primary outcome was pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).
次要结局
- Opioid Medication Consumption in Morphine Milligram Equivalents(Up to 4 days postoperatively)
- Length of Stay in the Post-anesthesia Care Unit (PACU)(At the time of discharge from PACU, Up to 1 day)
- Patient Satisfaction With Pain Management(At first postoperative visit, up to 30 days)
- Length of Hospital Stay(At the time of discharge from hospital, Up to 4 days)
- Postoperative Visual Analog Scale (VAS) Pain Scores(Up to first postoperative visit, maximum 30 days)