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

Not Applicable

Withdrawn

• Conditions: Post-operative Pain, Acute; Cesarean Section; Opioids; Harmful Use; Opioid Use Disorder
• Interventions: Device: Auricular percutaneous nerve field stimulator; Device: Sham auricular percutaneous nerve field stimulator

• Registration Number: NCT06434714
• Lead Sponsor: Inova Health Care Services

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-23
• Study First Posted: 2024-05-30
• Study Start: 2024-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-08
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 159

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bridge device	Auricular percutaneous nerve field stimulator	Bridge device placed in post-anesthesia care unit (PACU) and worn until end-of-life of the device (at 5 days) in addition to standard of care pain medications as per institutional policy
Sham device	Sham auricular percutaneous nerve field stimulator	Sham (non-functional) Bridge device placed in post-anesthesia care unit (PACU) and worn until 5 days post-delivery in addition to standard of care pain medications as per institutional policy

Primary Outcome Measures

Name	Time	Method
Total opioid intake on post-operative day 4	Four days	Total opioid intake in morphine milligram equivalents (MME) on post-operative day 4

Trial Locations

Locations (1)

Inova Fairfax Medical Campus; 🇺🇸 Falls Church, Virginia, United States