BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control

Not Applicable

Completed

Conditions: Pain, Postoperative
Opioid-use Disorder

Interventions: Other: Active control
Device: NSS-2 Bridge
Device: Inactive NSS-2 Bridge

Registration Number: NCT04365465

Lead Sponsor: Grace Lim, MD, MS

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 60

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Control	Active control	Participants in this arm will receive no device, only the standard postpartum pain control.
Active device	NSS-2 Bridge	Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
Placebo device	Inactive NSS-2 Bridge	Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.

Primary Outcome Measures

Name	Time	Method
Pain Scores With Movement	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 Outcome Measures

Name	Time	Method
PROMIS Pain Interference Survey	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.
Recovery Variables From Med Record: Readmission Due to Pain Issues	First week postoperatively	Readmission due to pain issues as abstracted from EMR during hospital stay.
BPI8 Survey	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
BPI25 Survey	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.
Device Tolerability Survey	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.
Recovery Variables From Med Record: Readmission	First week postoperatively	Readmission as abstracted from EMR during hospital stay.
PROMIS Pain Intensity Survey	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.
Opioid Consumption	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.
ObsQoR-11 Survey	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
Recovery Variables From Med Record: ICU Admission	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.