BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control

NCT04365465 | Completed Results FDA Device

• 2 other identifiers: STUDY19110257UL1TR001857
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain Scores With Movement

  Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.

  post-operative day 3

Secondary Outcomes (10)

• PROMIS Pain Intensity Survey

  Post-operative day 3

• PROMIS Pain Interference Survey

  Post-operative day 3

• Opioid Consumption

  Post-operative day 3

• ObsQoR-11 Survey

  Post-operative day 3

• Recovery Variables From Med Record: ICU Admission

  First week postoperatively

Study Arms (3)

Active device

EXPERIMENTAL

Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.

Device: NSS-2 Bridge

Placebo device

SHAM COMPARATOR

Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.

Device: Inactive NSS-2 Bridge

Active Control

ACTIVE COMPARATOR

Participants in this arm will receive no device, only the standard postpartum pain control.

Other: Active control

Interventions

NSS-2 Bridge DEVICE

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.

Active device

Inactive NSS-2 Bridge DEVICE

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.

Placebo device

Active control OTHER

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.

Active Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant
• Third trimester
• Cesarean delivery under neuraxial anesthesia
• Healthy, clean skin
• years or older

You may not qualify if:

• Not fluent in English (surveys are validated in English language), unable to participate in informed consent discussions, or unable to give informed consent for any reason
• Unable to participate fully in all study procedures for any reason
• Cesarean delivery under general anesthesia
• History of hemophilia
• Pacemakers or implantable electronic devices
• History of psoriasis

Sponsors & Collaborators

• Grace Lim, MD, MS: lead
• University of Pittsburgh: collaborator

Study Sites (1)

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, 15215, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Grace Lim, MD, MSc
• Organization: UPMC Magee-Womens Hospital

limkg2@upmc.edu

412-641-2179

Study Officials

• Grace Lim, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Among participants who receive a device, both the participant and care providers/investigators will be blinded to whether the device is active or placebo. There is no blinding among participants who do not receive a device.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control).

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 28, 2020
• Study Start: August 17, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: January 18, 2023
• Results First Posted: January 18, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)