BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 17, 2020

Primary Completion Date

June 30, 2021

Study Completion Date

June 30, 2021

Conditions
Opioid-use DisorderPain, Postoperative
Interventions
DEVICE

NSS-2 Bridge

The NSS-2 BRIDGE (Appendix 1) is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs.

DEVICE

Inactive NSS-2 Bridge

This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.

OTHER

Active control

Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.

Trial Locations (1)

15215

UPMC Magee Womens Hospital, Pittsburgh

All Listed Sponsors
collaborator

University of Pittsburgh

OTHER

lead

Grace Lim, MD, MS

OTHER

NCT04365465 - BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control | Biotech Hunter | Biotech Hunter