Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Postoperative narcotic medication use
研究概览
简要总结
Effective and safe control of pain after shoulder surgery is an important component of the post-surgical process. Patients who are comfortable in the early period after surgery are more satisfied with their experience and are better able to participate in rehabilitation exercises during their stay in the hospital. As surgeons and health care systems in the United States find themselves in the middle of an opioid epidemic, it is necessary to discover different options to provide patients pain relief that are both effective and safe in an effort to decrease the amount of pain medication used.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants having a primary rotator cuff repair
- •Age 18 and older
- •English speaking
- •Ability to complete surveys by phone or in person
- •Ability to provide informed consent
排除标准
- •Revision rotator cuff repair (RCR) cases
- •Participants having an open RCR
- •Allergies and/or medical contra-indications to study medications
- •Non-English speakers
- •Participants who are pregnant, plan to become pregnant and do not utilize adequate contraceptive means, or are currently breastfeeding (all patients who have the potential to be pregnant are administered a urine beta-HCG pregnancy test, with suspected false-positive or equivocal urine pregnancy tests followed by a more specific serum pregnancy test)
- •Rotator cuff repair needing Graft Augmentation
- •Known alcohol or narcotic abuse history
- •Existing contract with a pain specialist due to underlying preoperative pain syndrome
- •Preoperative opioid use within the 3 months prior to surgery
研究组 & 干预措施
Group 1: Shoulder Block using Exparel
Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + bupivacaine given in their shoulder block before surgery.
干预措施: Liposomal bupivacaine (Drug)
Group 1: Shoulder Block using Exparel
Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + bupivacaine given in their shoulder block before surgery.
干预措施: Bupivacaine Hcl 0.5% Inj (Drug)
Group 2: Shoulder Block using Exparel + Dexamethasone
Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery.
干预措施: Liposomal bupivacaine (Drug)
Group 2: Shoulder Block using Exparel + Dexamethasone
Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery.
干预措施: Bupivacaine Hcl 0.5% Inj (Drug)
Group 2: Shoulder Block using Exparel + Dexamethasone
Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Postoperative narcotic medication use
时间窗: 14 days
Participants will be asked to record the amount of medication they take to control pain after surgery
Postoperative pain levels
时间窗: 14 days
This will be measured by providing participants the visual analog scale (VAS) questionnaire as well as a postoperative pain recording diary to complete after surgery
次要结局
未报告次要终点