BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control
NCT ID: NCT04365465
Last Updated: 2023-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-08-17
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active device
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge
The NSS-2 BRIDGE (Appendix 1) is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs.
Placebo device
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge
This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
Active Control
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control
Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
Interventions
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NSS-2 Bridge
The NSS-2 BRIDGE (Appendix 1) is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs.
Inactive NSS-2 Bridge
This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
Active control
Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
Eligibility Criteria
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Inclusion Criteria
* Third trimester
* Cesarean delivery under neuraxial anesthesia
* Healthy, clean skin
* 18 years or older
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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University of Pittsburgh
OTHER
Grace Lim, MD, MS
OTHER
Responsible Party
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Grace Lim, MD, MS
Assistant Professor
Principal Investigators
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Grace Lim, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY19110257
Identifier Type: -
Identifier Source: org_study_id
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