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

January 30, 2025 updated by: Inova Health Care Services
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Device: Auricular percutaneous nerve field stimulator
Percutaneous nerve field stimulator device placed on the ear for 5 days
Other Names:
  • Bridge
Sham Comparator: 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
Device: Sham auricular percutaneous nerve field stimulator
Non-functioning percutaneous nerve field stimulator device placed on the ear for 5 days
No Intervention: Standard of care
Standard of care pain medications only as per institutional policy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioid intake on post-operative day 4
Time Frame: Four days
Total opioid intake in morphine milligram equivalents (MME) on post-operative day 4
Four days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Investigators

  • Principal Investigator: Ellen M Murrin, DO, Inova Health Systems
  • Principal Investigator: Antonio Saad, MD, Inova Health Systems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INOVA-2023-131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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