Status:
WITHDRAWN
Sprix for Postoperative Pain Control Following Gynecologic Surgery
Lead Sponsor:
University of Louisville
Conditions:
Post Operative Pain Control
Narcotic Use
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The ongoing opioid epidemic has altered both how physicians prescribe narcotics and patients' perceptions of those prescriptions. Along with increased scrutiny regarding the quantity of opioids that b...
Eligibility Criteria
Inclusion
- Age ≥ 18 years of age
- Weight ≥ 110lbs
- English Speaking and Reading
- All consecutive, consenting female patients undergoing Pelvic Organ Prolapse (POP) surgery - vaginal prolapse surgery, laparoscopic vaginal prolapse surgery or robotic assisted vaginal prolapse surgery - with or without Bilateral or Unilateral Salpingoopherectomy, with or without concomitant hysterectomy, with or without urinary anti-incontinence surgery
Exclusion
- Patients taking opioids chronically at the time of surgery
- History of Coronary Artery Bypass Graft (CABG)
- History of peptic ulcer disease or bleeding in the stomach or intestines
- History of asthma attack, hives, or other allergic reaction with aspirin or any other Non-Steroidal Anti-inflammatory Drug (NSAID)
- Uncontrolled hypertension at the time of consent and/or surgery
- History of renal impairment as defined by blood creatinine of 1.1 or greater at any time
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04444830
Start Date
January 1 2021
End Date
September 21 2021
Last Update
July 29 2022
Active Locations (1)
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1
University of Louisville Hospital
Louisville, Kentucky, United States, 40203