A Randomized-controlled Trial of Post-operative Opiate Quantities After Urogynecologic Surgery

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 adverse event or unanticipated events will be reported immediately to the IRB using IRB WebKit. All events will be recorded and kept in a research binder assigned to this study in a locked office. Monthly reviews during the study period will be done by all involved study staff members to ensure that events are not occurring, and if they are, that they are being handled and reported properly. The study will be terminated if over 50% of patients in the decreased opiate group request more or stronger medication during interim analysis or have >20% decreased satisfaction to the control group; this will be assessed monthly at the reviews mentioned above.

STUDY PROCEDURES Study Identification and Recruitment Potential subjects will be identified by members of the Center for Urogynecology and Pelvic Reconstructive Surgery at the Cleveland Clinic Main Campus. At the time of decision for surgery, attending staff who have been counseled about how to discuss the study will bring up the study. Fliers will be available to give to patients. Patients will be offered a visit with research staff at this time. They also will have the opportunity to meet research staff at their preop visit which is when consent forms would be signed and prescriptions given. Phone calls from research staff will also be made to interested patients or potential subjects. Eligible patients who agree to participate will be provided written informed consent administered by the collaborators listed on the IRB. Consents can be obtained at the Cleveland Clinic Main Campus or Fairview hospital.

Randomization All subjects will be scheduled for surgery by their surgeon. Consenting patients who meet inclusion criteria will be randomized into one of two arms: "routine opiate prescription" or "decreased opiate prescription" according to a computer-generated randomization schedule with random block sizes with the use of the JMP statistical software. The routine arm will receive twenty-eight tabs of oxycodone at discharge - thirty was the usual number prescribed for these surgeries, but new opiate prescribing guidelines limit the amount prescribed as 28 tablets based on morphine equivalent doses and a 7 day prescription limit. The decreased prescription arm will receive five tabs of oxycodone. All subjects will be instructed to use the opiate pills only as a back-up pain plan after the NSAID and acetaminophen. All subjects will be instructed to use the same schedule: schedule ibuprofen and acetaminophen for 3 days followed by these as needed. Subjects will have their prescriptions filled on day of discharge at the Cleveland Clinic pharmacy based on the randomization in addition to the following medications that per protocol all patients will receive unless contraindicated due to allergy/medication interaction: Colace (100mg tablets to take PO BID, #60), Miralax (17gm packets to take PO daily, #30), and ibuprofen (600mg tablets to take PO every 6 hours for 3 days postoperatively then as needed, #60. The use of scheduled NSAIDs is based on benefit of multimodal therapy in an effort to minimize opiate use. Despite these medications' potential effect to decrease effect seen between the study groups, their use in the trial provides increased clinical applicability.