CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 65 enrolled
Drug / intervention
Physician directed opioid prescribing +1 moredrug
Likely dose
Physician directed opioid prescribing 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03805386
NCT03805386Phase 3Completed

Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery

Mayo Clinic·interventional·Posted Jan 15, 2019·Updated Feb 21, 2021

In Brief

A Phase 3 clinical trial evaluating Physician directed opioid prescribing and Patient directed opioid prescribing for Gynecology and 2 related conditions. Completed, enrolled 65 participants across 1 site.

Detailed Summary

We would like to evaluate and optimize opioid prescribing after minimally invasive hysterectomy. Currently, our standard prescribing is 150 oral morphine equivalents. However, recent studies show that half of the opioids prescribed are not used. We would like to include the patient in the decision making of the opioid prescribing. We have designed a randomized controlled trial to prescribe standard (150 oral morphine equivalents) or patient directed (less than or equal to 150 oral morphine equivalents) for pain control. We hypothesize that with patient input, there will be a higher utilization of the opioids prescribed. Also, we anticipate a lower number of opioids used overall. This study will help us optimize opioid prescribe and evaluate whether patient input can help in this important measure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 15, 2019
Enrollment StartJan 15, 2019
Primary CompletionApr 15, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.5 years ago

Interventions

Physician directed opioid prescribingdrug

Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.

Patient directed opioid prescribingdrug

Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.