NCT04365465

BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control

BRIDGE Device: Percutaneous Auricular Nerve Field Stimulation as Alternative Post-Cesarean Delivery Analgesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Grace Lim, MD, MS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD). The purpose of this pilot investigation is to establish feasibility/acceptability of the trial design.

Detailed description

This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control). The devices will be placed while women are still feeling pain relief from labor epidural analgesia (after delivering vaginally) or from spinal or epidural anesthesia (after delivering by cesarean). By applying the devices while women are still relatively pain-free, a preventative/pre-emptive approach to pain management in women at risk for severe postpartum pain is taken. The study will enroll women with and without OUD and follow them for five days postpartum.

Conditions

• Opioid-use Disorder
• Pain, Postoperative

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-17
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2020-04-28
• Last updated: 2023-01-18
• Results posted: 2023-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study