Evaluation of Bridge Device in Pain Management for Outpatient Rotator Cuff Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Oral Opioid Use POD 1
研究概览
简要总结
The objective of the trial is to investigate the efficacy of the Bridge device in reducing post-operative pain and post-operative opioid consumption in patients undergoing rotator cuff surgery with the typical mode of anesthesia, nerve block plus propofol sedation.
详细描述
The interscalene block is the gold standard for postoperative pain management following rotator cuff surgery. However, the duration of the block does not cover rehabilitation. Therefore, in most cases, patients are discharged from the surgical center with an opioid prescription. There is a growing need to investigate complementary, non-pharmacologic pain-management methods. The Bridge device, which provides auricular neuromodulation of various cutaneous nerves near the ear, is manufactured by Masimo and previously FDA-approved to reduce symptoms of opioid withdrawal. It is a promising technology that could help relieve post-operative pain without exposing patients to the adverse effects of opioids or other pain-relieving medications. The objective of the trial is to investigate the efficacy of the Bridge device in reducing post-operative pain and post-operative opioid consumption in patients undergoing rotator cuff surgery with the typical mode of anesthesia, nerve block plus propofol sedation. Those enrolled will be assigned to a study group and compared to historic cohort (control group). Historic control group involves patients that underwent same surgical procedure performed at the surgical center involved in the study, by the same surgical operator, between 2020 and 2023.
*Prior to study enrollment, the outcome measure timepoints were updated to postoperative days (POD) 1, 3, 5, and 7. This was largely due to pain trajectories in surgical populations often follow a predictable, nonlinear course, with meaningful fluctuations most apparent on alternating days rather than daily increments. By assessing the outcome measures on POD 1, 3, 5, and 7, the revised scheduled timepoints continues to capture initial peak (POD 1), early recovery phase (POD3), the late recovery phase (POD 5), and the resolution/transition phase (POD 7) regarding pain trajectories.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 18 years of age
- •Willing and able to provide informed consent
- •Scheduled to undergo elective rotator cuff surgery at UPMC
- •No pre-existing medical conditions which would prevent application of the Bridge device on auricle of ear (i.e., skin infection, rash)
排除标准
- •Opioids dependence
- •Chronic pain condition with daily opioid use
- •Anatomical malformation, which may interfere with placement of the nerve block
- •Raynaud's disease diagnosis
- •Vasculopathy
- •Hemophilia or other coagulopathy, or use of active anticoagulation other than aspirin
- •Patient refusal
- •Pacemaker
- •Pre-existing medical conditions which would prevent application of the Bridge device on auricle of ear (i.e., skin infection, rash)
- •Psoriasis vulgaris
研究组 & 干预措施
Bridge Percutaneous Nerve Field Stimulator
The case group (n = 15) will receive an activated Bridge device after surgery and continuing wearing the device until post-operative day (POD) 7.
干预措施: Bridge Percutaneous Nerve Field Stimulator (Device)
Historical Control
Historical Controls (n=27) who previously had arthroscopic ambulatory rotator cuff surgery, all other factors are the same as the intervention group (multimodal analgesia, etc.)
结局指标
主要结局
Oral Opioid Use POD 1
时间窗: Post-Operative Day 1
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Oral Opioid Use POD 5
时间窗: Post-Operative Day 5
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Oral Opioid Use POD 3
时间窗: Post-Operative Day 3
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
Oral Opioid Use POD 7
时间窗: Post-Operative Day 7
This outcome will be measured by total Oral Morphine Equivalents (OME, mg) abstracted from the medical records.
次要结局
- Self-Reported Pain Scores POD 1(Post-Operative Day 1)
- Self-Reported Pain Scores POD 3(Post-Operative Day 3)
- Self-Reported Pain Scores POD 5(Post-Operative Day 5)
- Self-Reported Pain Scores POD 7(Post-Operative Day 7)
- Number of Participants Who Self-Reported Oral Opioid Use POD 5(Post-Operative Day 5)
- Number of Participants Who Self-Reported Oral Opioid Use POD 7(Post-Operative Day 7)
- Adverse Events Related to Opioid POD 5(Post-Operative Day 5)
- Adverse Events Related to Opioid POD 7(Post-Operative Day 7)
- Local Adverse Events on Ear Related to Device POD 1(Post-operative Day 1)
- Local Adverse Events on Ear Related to Device POD 3(Post-operative Day 3)
- Local Adverse Events on Ear Related to Device POD 5(Post-operative Day 5)
- Local Adverse Events on Ear Related to Device POD 7(Post-operative Day 7)
研究者
Steven Orebaugh
Professor
University of Pittsburgh