BRIDGE Device: Percutaneous Auricular Nerve Field Stimulation as Alternative Post-Cesarean Delivery Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain Scores With Movement
研究概览
简要总结
This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD). The purpose of this pilot investigation is to establish feasibility/acceptability of the trial design.
详细描述
This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control). The devices will be placed while women are still feeling pain relief from labor epidural analgesia (after delivering vaginally) or from spinal or epidural anesthesia (after delivering by cesarean). By applying the devices while women are still relatively pain-free, a preventative/pre-emptive approach to pain management in women at risk for severe postpartum pain is taken. The study will enroll women with and without OUD and follow them for five days postpartum.
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
Among participants who receive a device, both the participant and care providers/investigators will be blinded to whether the device is active or placebo. There is no blinding among participants who do not receive a device.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Third trimester
- •Cesarean delivery under neuraxial anesthesia
- •Healthy, clean skin
- •18 years or older
排除标准
- •Not fluent in English (surveys are validated in English language), unable to participate in informed consent discussions, or unable to give informed consent for any reason
- •Unable to participate fully in all study procedures for any reason
- •Cesarean delivery under general anesthesia
- •History of hemophilia
- •Pacemakers or implantable electronic devices
- •History of psoriasis
结局指标
主要结局
Pain Scores With Movement
时间窗: post-operative day 3
Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
次要结局
- PROMIS Pain Interference Survey(Post-operative day 3)
- Recovery Variables From Med Record: Readmission Due to Pain Issues(First week postoperatively)
- BPI8 Survey(Post-operative day 3)
- BPI25 Survey(Post-operative day 3)
- Device Tolerability Survey(Post-Op Day 7)
- Recovery Variables From Med Record: Readmission(First week postoperatively)
- Opioid Consumption(Post-operative day 3)
- PROMIS Pain Intensity Survey(Post-operative day 3)
- ObsQoR-11 Survey(Post-operative day 3)
- Recovery Variables From Med Record: ICU Admission(First week postoperatively)
研究者
Grace Lim, MD, MS
Assistant Professor
University of Pittsburgh