Status:
UNKNOWN
Too Much of a Good Thing? Impact of Initial Prescription Size in Post-cesarean Section Pain Management
Lead Sponsor:
Carilion Clinic
Collaborating Sponsors:
Virginia Polytechnic Institute and State University
Conditions:
Post Operative Pain
Eligibility:
FEMALE
19-40 years
Phase:
PHASE4
Brief Summary
This is a randomized controlled trial involving 170 opioid naive women ages 19-40 undergoing scheduled C-sections at Carilion Roanoke Memorial Hospital. Participants are randomized to receive either 1...
Detailed Description
All faculty scheduled cesarean deliveries will be eligible for possible enrollment. Once patients are scheduled for delivery, their providers will grant permission for potential participation in the s...
Eligibility Criteria
Inclusion
- Female
- Age 19-40 years old
- Pregnant
- Scheduled to undergo cesarean section at Carilion Roanoke Memorial Hospital
- opioid naïve (defined as no opioid use within 30 days of surgery
Exclusion
- History of chronic pain
- History of opioid use disorder
- History of any known intolerance or allergies to analgesics
- Women with postoperative complications (hysterectomy during or after birth, bowel or bladder injury during birth, need for re-operation, or immediate wound complication)
- Language barrier preventing screening or consent
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT05360433
Start Date
November 1 2020
End Date
December 1 2022
Last Update
May 4 2022
Active Locations (1)
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1
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24014