Status:
COMPLETED
Post-operative Patient Positioning Device for Improvement of Post-Operative Pain
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
GSquared Medical, LLC
Conditions:
Pain, Postoperative
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This paucity of evidence supporting or dissuading the use of postoperative abdominal support following cesarean section for the reduction of postoperative pain leaves important clinical questions unan...
Detailed Description
BACKGROUND: Postoperative pain has significant short- and long-term implications for parturients undergoing cesarean delivery. Poorly controlled postoperative pain can interfere with the women's abil...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Cesarean delivery
- \<36 hours post-delivery
Exclusion
- Vertical skin incision
- Inability to place device superior to incision
- Presence of surgical drain
- Opioid use disorder
- Chronic opioid use (\> 14 consecutive days during pregnancy)
- Allergy to device adhesive
- Active COVID-19 infection
- Patient unable to consent
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2022
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT04797637
Start Date
April 1 2021
End Date
July 20 2022
Last Update
August 22 2023
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232