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Completed

NCT Number: NCT04365465

BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, 15215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  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.

  4. 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

  5. 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.

  6. Recovery Variables From Med Record: Readmission

    Time frame: First week postoperatively

    Readmission as abstracted from EMR during hospital stay.

  7. 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.

  8. 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

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Grace Lim, MD, MS

Other

Collaborators

  • University of Pittsburgh

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2020
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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