BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control

Pain, Postoperative Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Pain, Postoperative

• NCT number: NCT04365465
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Completed
• Phase: N/A
• Start date: August 17, 2020
• Completion date: June 30, 2021