N/A
N=118
A Randomized-controlled Trial of Post-operative Opiate Quantities After Urogynecologic Surgery
Postoperative Pain · Opioid Use
Bottom Line
View on ClinicalTrials.gov: NCT03319277 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Patients Reporting Adequate Satisfaction — 55; 53 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decreased opiate prescription (Other); Routine opiate prescription (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Cleveland Clinic
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Reporting Adequate Satisfaction |
55; 53 | — |
| SECONDARY Number of Opiate Tablets Used by Patients |
3; 1 | — |
| SECONDARY Number of Patients Willing to Destroy Excess Remaining Opioid Tablets |
51; 50 | — |
Summary
This is a randomized controlled trial to determine the effect of decreased post-operative prescriptions of opiate medications after urogynecologic surgery.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03319277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.