CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
NSS-2 Bridge +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04365465
NCT04365465N/ACompleted
CompareCT.gov

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

Grace Lim, MD, MS·interventional·Posted Apr 28, 2020·Updated Jan 18, 2023

In Brief

A clinical study evaluating NSS-2 Bridge, Inactive NSS-2 Bridge, and 1 other intervention for Opioid-use Disorder and Pain, Postoperative. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-use Disorder, Pain, Postoperative
CountriesUnited States
CollaboratorsUniversity of Pittsburgh

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 28, 2020
Enrollment StartAug 17, 2020
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.2 years ago

Interventions

NSS-2 Bridgedevice

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.

Inactive NSS-2 Bridgedevice

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.

Active controlother

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.