Clinical trial NCT04365465: BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control
Official title: BRIDGE Device: Percutaneous Auricular Nerve Field Stimulation as Alternative Post-Cesarean Delivery Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Pain, Postoperative
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2020-04-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Scores With Movement
timeFrame: post-operative day 3
Secondary outcomes:
measure: PROMIS Pain Intensity Survey
timeFrame: Post-operative day 3
measure: PROMIS Pain Interference Survey
timeFrame: Post-operative day 3
measure: Opioid Consumption
timeFrame: Post-operative day 3
measure: ObsQoR-11 Survey
timeFrame: Post-operative day 3
measure: Recovery Variables From Med Record: ICU Admission
timeFrame: First week postoperatively
measure: Recovery Variables From Med Record: Readmission
timeFrame: First week postoperatively
measure: Recovery Variables From Med Record: Readmission Due to Pain Issues
timeFrame: First week postoperatively
measure: BPI8 Survey
timeFrame: Post-operative day 3
measure: BPI25 Survey
timeFrame: Post-operative day 3
measure: Device Tolerability Survey
timeFrame: Post-Op Day 7
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Magee Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Grace Lim, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: