BRIDGE Device: Percutaneous Auricular Nerve Field Stimulation as Alternative Post-Cesarean Delivery Analgesia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid-use Disorder
- Sponsor
- Grace Lim, MD, MS
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pain Scores With Movement
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Grace Lim, MD, MS
Assistant Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
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
- PROMIS Pain Interference Survey(Post-operative day 3)
- Recovery Variables From Med Record: Readmission Due to Pain Issues(First week postoperatively)
- BPI8 Survey(Post-operative day 3)
- BPI25 Survey(Post-operative day 3)
- Device Tolerability Survey(Post-Op Day 7)
- Recovery Variables From Med Record: Readmission(First week postoperatively)
- Opioid Consumption(Post-operative day 3)
- PROMIS Pain Intensity Survey(Post-operative day 3)
- ObsQoR-11 Survey(Post-operative day 3)
- Recovery Variables From Med Record: ICU Admission(First week postoperatively)