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

NCT06434714 | Withdrawn FDA Device

• 1 other identifier: INOVA-2023-131
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cesarean section; post-operative pain; opioid abuse; non-pharmacologic therapy

Outcome Measures

Primary Outcomes (1)

• Total opioid intake on post-operative day 4

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

  Four days

Study Arms (3)

Bridge device

ACTIVE COMPARATOR

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

Sham device

SHAM COMPARATOR

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

Standard of care

NO INTERVENTION

Standard of care pain medications only as per institutional policy

Interventions

Auricular percutaneous nerve field stimulator DEVICE

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

Also known as: Bridge

Bridge device

Sham auricular percutaneous nerve field stimulator DEVICE

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

Sham device

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Related Publications (4)

• Osmundson SS, Min JY, Grijalva CG. Opioid prescribing after childbirth: overprescribing and chronic use. Curr Opin Obstet Gynecol. 2019 Apr;31(2):83-89. doi: 10.1097/GCO.0000000000000527.

  PMID: 30789842 BACKGROUND

• Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.

  PMID: 26996986 BACKGROUND

• Chelly JE, Monroe AL, Planinsic RM, Tevar A, Norton BE. Auricular field nerve stimulation using the NSS-2 BRIDGE(R) device as an alternative to opioids following kidney donor surgery. J Complement Integr Med. 2021 Nov 1;19(2):449-454. doi: 10.1515/jcim-2021-0208. eCollection 2022 Jun 1.

  PMID: 34714990 BACKGROUND

• Lim G, LaSorda KR, Monroe AL, Chelly JE. Auricular percutaneous nerve field stimulator device as alternative therapy for Cesarean delivery analgesia: proof of concept. Can J Anaesth. 2019 Dec;66(12):1522-1523. doi: 10.1007/s12630-019-01465-x. Epub 2019 Aug 20. No abstract available.

  PMID: 31432323 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Antonio Saad, MD

  Inova Health Systems

  PRINCIPAL INVESTIGATOR

• Ellen M Murrin, DO

  Inova Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded, placebo-controlled, 3 arm randomized controlled trial

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: June 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)