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

NCT06434714 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-02-03

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Auricular percutaneous nerve field stimulator

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

DEVICE

Sham auricular percutaneous nerve field stimulator

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

Sponsors & Collaborators

  • Inova Health Care Services

    lead OTHER

Principal Investigators

  • Antonio Saad, MD · Inova Health Systems

  • Ellen M Murrin, DO · Inova Health Systems

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2025-08-31
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06434714 on ClinicalTrials.gov