Status:
COMPLETED
BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control
Lead Sponsor:
Grace Lim, MD, MS
Collaborating Sponsors:
University of Pittsburgh
Conditions:
Opioid-use Disorder
Pain, Postoperative
Eligibility:
FEMALE
18+ years
Phase:
NA
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 pur...
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 pa...
Eligibility Criteria
Inclusion
- Pregnant
- Third trimester
- Cesarean delivery under neuraxial anesthesia
- Healthy, clean skin
- 18 years or older
Exclusion
- 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
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04365465
Start Date
August 17 2020
End Date
June 30 2021
Last Update
January 18 2023
Active Locations (1)
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1
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15215