BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control

Grace Lim, MD, MS

Status: Completed

Conditions: Opioid-use Disorder; Pain, Postoperative

Treatments: Device: Inactive NSS-2 Bridge; Other: Active control; Device: NSS-2 Bridge

Study type: Interventional

Funder types: Other

Identifiers

NCT04365465

STUDY19110257

UL1TR001857 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

Active device

Experimental group

Description:

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

Treatment:

Device: NSS-2 Bridge

Placebo device

Sham Comparator group

Description:

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

Treatment:

Device: Inactive NSS-2 Bridge

Active Control

Active Comparator group

Description:

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

Treatment:

Other: Active control