Status:
COMPLETED
A Randomized-controlled Trial of Post-operative Opiate Quantities After Urogynecologic Surgery
Lead Sponsor:
The Cleveland Clinic
Conditions:
Postoperative Pain
Opioid Use
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a randomized controlled trial to determine the effect of decreased post-operative prescriptions of opiate medications after urogynecologic surgery.
Detailed Description
This is a randomized controlled trial to assess the hypothesis that patients prescribed fewer or no opiates will have no difference in satisfaction with pain control. Safety/Data Monitoring: Any adv...
Eligibility Criteria
Inclusion
- Women 18 years or older
- Women scheduled to undergo minimally invasive surgery within the urogynecology division at Cleveland Clinic with a plan to stay one night in the hospital afterwards for a benign indication which includes:
- Vaginal hysterectomies with prolapse repair
- Sacrospinous ligament fixations
- Hysteropexy
- Sacrocolpopexy
- Women able to provide consent for research participation and to sign an informed consent
Exclusion
- Women with chronic pain or chronic pain syndrome
- Women undergoing concurrent bowel surgery
- Women with pre-operative chronic opiate use
- Inability to comprehend written and/or spoken English
- Inability to provide informed consent
- Inability to take oxycodone
- Inability to take acetaminophen due to allergy or liver disease
- Women will be excluded if they undergo an unplanned laparotomy
- Pain catastrophization score
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2019
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03319277
Start Date
October 13 2017
End Date
June 25 2019
Last Update
October 31 2019
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195