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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-operative Pain, Acute Cesarean Section Opioid Use Disorder Opioids; Harmful Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded, placebo-controlled, 3 arm randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Bridge device

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

Group Type ACTIVE_COMPARATOR

Auricular percutaneous nerve field stimulator

Intervention Type DEVICE

Percutaneous nerve field stimulator device placed on the ear for 5 days

Sham device

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

Group Type SHAM_COMPARATOR

Sham auricular percutaneous nerve field stimulator

Intervention Type DEVICE

Non-functioning percutaneous nerve field stimulator device placed on the ear for 5 days

Standard of care

Standard of care pain medications only as per institutional policy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Auricular percutaneous nerve field stimulator

Percutaneous nerve field stimulator device placed on the ear for 5 days

Intervention Type DEVICE

Sham auricular percutaneous nerve field stimulator

Non-functioning percutaneous nerve field stimulator device placed on the ear for 5 days

Intervention Type DEVICE

Other Intervention Names

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Bridge

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes