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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06434714
• Other study ID #: INOVA-2023-131
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Inova Fairfax Hospital
• Contact: Antonio Saad, MD
• Phone: 7037766040
• Email: antonio.saad[@]inova.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 159
• Est. completion date: September 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section
• Opioid Use Disorder
• Opioid-Related Disorders
• Opioids; Harmful Use
• Pain, Postoperative

Intervention

Device:
• Auricular percutaneous nerve field stimulator
Percutaneous nerve field stimulator device placed on the ear for 5 days
• Sham auricular percutaneous nerve field stimulator
Non-functioning percutaneous nerve field stimulator device placed on the ear for 5 days

Locations

Country	Name	City	State
United States	Inova Fairfax Medical Campus	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Fairfax Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total opioid intake on post-operative day 4	Total opioid intake in morphine milligram equivalents (MME) on post-operative day 4	Four days