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临床试验/NCT06434714
NCT06434714撤回不适用

Management of Postoperative Pain After Cesarean Delivery Using Bridge Auricular Percutaneous Nerve Field Stimulator

Inova Health Care Services2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2024年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
159
试验地点
2
主要终点
Total opioid intake on post-operative day 4

研究概览

简要总结

Post-cesarean section (CS) pain is commonly treated with acetaminophen, ibuprofen, and opioid medications as needed following delivery. About 300,000 women annually who were exposed to opioids after CS will go on to use opioids chronically. Reducing the quantity of post-CS opioids has been shown to decrease the amount of opioids used without compromising pain control. Bridge is a small device that sits on the outer ear and works similarly to a transcutaneous electrical nerve stimulation (TENS) unit to decrease pain sensation without medications. It has been shown to effectively reduce pain to decrease medication requirements after surgeries. This study aims to see if women receiving the Bridge device use need less pain medication than those without the device.

详细描述

Cesarean delivery is one of the most performed surgeries in the U.S. with approximately 1.15 million surgeries performed annually. Despite this, postoperative pain management remains a challenge. Prescribed total milligram morphine equivalents (MMEs) can range from 25 MMEs (equivalent to 3.3 oxycodone 5-mg tablets) to 1,950 MMEs (equivalent to 260 oxycodone 5-mg tablets). Additionally, the post discharge analgesia prescription is not correlated with the 24-hour predischarge opioid use or pain score. Most U.S. women who are prescribed opioids after a cesarean delivery receive at least 10 more tablets than necessary. A study looking at individualizing opioid prescriptions based on inpatient requirements found that women used about 60% of their prescription, regardless of the amount of opioids prescribed. Decreasing opioid requirement after cesarean delivery, can decrease women's exposure to opioids, reduce the risk of neonatal central nervous system depression due to exposure in breastmilk, and limit the potential for extra opioids from unused, filled prescriptions to fall into the wrong hands. Post-cesarean mothers use opioids for a median of 8 days after delivery. Bridge is a minimally invasive device shown in previous studies to reduce pain medication requirements in the post-operative acute recovery period. The device is a auricular percutaneous electrical nerve stimulator that modulates pain receptors leading to reduced pain sensation. This trial study to examine the utility of the Bridge device as an adjunct to standard of care post-cesarean pain regimens (acetaminophen, ibuprofen or ketorolac, and oxycodone or other similar opioid). Post-cesarean patients will be randomized in a 1:1:1 ratio to Bridge device, sham device, or standard of care treatment and followed through the postpartum period.

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

Participants will be randomized to either active Bridge device, sham (non-functional) device, or standard of care post-operative pain regimen. Participants, care providers, and investigators will be blinded to those in active or sham device groups.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female 18 years or older able to provide informed consent in English or Spanish.
  • Scheduled for cesarean delivery under neuraxial anesthesia.
  • Intact skin surface behind and around the ear at the site of electrode application.

排除标准

  • Active drug abuse.
  • Chronic opioid user.
  • Severe chronic pain.
  • Hemophilia.
  • Cardiac pacemaker or implantable electronic devices.
  • Psoriasis vulgaris or other skin conditions precluding safe device application.
  • Previous history of sensitivity to compound benzoin tincture.
  • Hearing aid precluding proper placement of the device or removing which interferes with their hearing ability.
  • Subject is concurrently participating in another research study with an investigational drug or medical device that in the Investigator's opinion could impact subject safety or study results.
  • Subject with reasons to maintain an epidural beyond operative room.
  • Subject with complex surgery or subject who may need more than a cesarean surgery with possible tubal sterilization procedure.
  • Subject is deemed not suitable for the study at the discretion of the principal Investigator.

结局指标

主要结局

Total opioid intake on post-operative day 4

时间窗: Four days

Total opioid intake in morphine milligram equivalents (MME) on post-operative day 4

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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