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Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery

NCT03805386 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-02-21

Study results available
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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.

Conditions

  • Gynecology
  • Surgery
  • Opioid Use

Interventions

DRUG

Physician directed opioid prescribing

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

DRUG

Patient directed opioid prescribing

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

Sponsors & Collaborators

Principal Investigators

  • Johnny Yi · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2020-04-15
Completion
2020-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03805386 on ClinicalTrials.gov