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BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control

NCT04365465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-18

Study results available
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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.

Conditions

  • Opioid-use Disorder
  • Pain, 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.

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • Grace Lim, MD, MS

    lead OTHER

Principal Investigators

  • Grace Lim, MD, MS · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-17
Primary Completion
2021-06-30
Completion
2021-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04365465 on ClinicalTrials.gov