BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control

December 21, 2022 updated by: Grace Lim, MD, MS

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15215
        • UPMC Magee Womens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active device
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
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.
Sham Comparator: Placebo device
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
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.
Active Comparator: Active Control
Participants in this arm will receive no device, only the standard postpartum pain control.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores With Movement
Time Frame: post-operative day 3
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Pain Intensity Survey
Time Frame: Post-operative day 3
PROMIS Pain Intensity Survey is self-reported by participants and includes the options: "Had no pain", "Mild", "Moderate", "Severe", or "Very Severe". These responses range from 1 point (had no pain) to 5 points (very severe). This means the participant raw score can be between 3 points and 15 points.
Post-operative day 3
PROMIS Pain Interference Survey
Time Frame: Post-operative day 3
PROMIS Pain Interference Survey is self-reported by participants and includes the options: "Not at all", "A little bit", "Somewhat", "Quite a bit", or "Very Much". These responses range from 1 point (not at all) to 5 points (very much). This means the participant raw score can be between 3 points and 15 points.
Post-operative day 3
Opioid Consumption
Time Frame: Post-operative day 3
Total opioid consumption as abstracted from EMR during hospital stay. The number of participants using opioids by post-operative day 3 will be recorded by binary responses of 'yes' or 'no' via EMR data.
Post-operative day 3
ObsQoR-11 Survey
Time Frame: Post-operative day 3
11 item survey evaluation of postoperative symptoms and independence as self reported by participants. Scale for this tool is 0-10 with 0 being "very poor" and 10 being "excellent". Total score will be calculated for each participant. Minimum score = 0 and Maximum score = 110
Post-operative day 3
Recovery Variables From Med Record: ICU Admission
Time Frame: First week postoperatively
ICU admission as abstracted from EMR during hospital stay. This will be recorded with a binary response of 0. no or 1. yes if participant is admitted to the ICU in the first week post-op.
First week postoperatively
Recovery Variables From Med Record: Readmission
Time Frame: First week postoperatively
Readmission as abstracted from EMR during hospital stay.
First week postoperatively
Recovery Variables From Med Record: Readmission Due to Pain Issues
Time Frame: First week postoperatively
Readmission due to pain issues as abstracted from EMR during hospital stay.
First week postoperatively
BPI8 Survey
Time Frame: Post-operative day 3
1 item survey of percentage of relief experienced from pain management as self-reported by participants. Percentage options: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100. Participant will self-report on post-operative day 3. Percentages will be converted to a 0-10 scale. A score of 0 (minimum value) indicates better outcomes and a score of 10 (maximum value) indicates worse outcomes
Post-operative day 3
BPI25 Survey
Time Frame: Post-operative day 3
1 item survey of pain medication use frequency as self-reported by participants. Scored on a 1-5 scale, with 1 indicating better outcomes and 5 indicating worse outcomes.
Post-operative day 3
Device Tolerability Survey
Time Frame: Post-Op Day 7
Device tolerability will be recorded using a Visual Analogue Scale (VAS). This will be self-reported by participants. Response options: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100. 0 = no pain at all and 100 = severe intolerable pain.
Post-Op Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grace Lim, MD, MS

Collaborators

University of Pittsburgh

Investigators

  • Principal Investigator: Grace Lim, MD, MS, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY19110257
  • UL1TR001857 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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