BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Opioid-use Disorder, Pain, Postoperative

Intervention / Treatment
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* Device: NSS-2 Bridge
* Device: Inactive NSS-2 Bridge
* Other: Active control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active device<br>Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section. | Device: NSS-2 Bridge<br>* 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.<br>|
| Sham Comparator: Placebo device<br>Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section. | Device: Inactive NSS-2 Bridge<br>* 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.<br>|
| Active Comparator: Active Control<br>Participants in this arm will receive no device, only the standard postpartum pain control. | Other: Active control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Pain Intensity Survey | 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 | 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 | 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 | 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 | 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 | Readmission as abstracted from EMR during hospital stay. | First week postoperatively | 
| Recovery Variables From Med Record: Readmission Due to Pain Issues | Readmission due to pain issues as abstracted from EMR during hospital stay. | First week postoperatively | 
| BPI8 Survey | 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 | 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 | 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 |