NCT03805386

Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery

Completed Phase 2, PHASE3 Results posted Last updated 21 February 2021

What this trial tests

Phase 2, PHASE3 trial testing Physician directed opioid prescribing in Gynecology in 65 participants. Completed in 15 April 2020.

Timeline

15 January 2019

Primary endpoint
15 April 2020

15 April 2020

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	65
Start date	15 January 2019
Primary completion	15 April 2020
Estimated completion	15 April 2020
Sites	1 location across United States

Drugs / interventions tested

• Physician directed opioid prescribing — full drug profile →
• Patient directed opioid prescribing — full drug profile →

Conditions studied

• Gynecology — all drugs for Gynecology →
• Surgery — all drugs for Surgery →
• Opioid Use — all drugs for Opioid Use →

Sponsor

Mayo Clinic

Who can join

18 and older, female only, with Gynecology or Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

# of Opioid Pills Consumed Primary · 6 weeks postop

Percent utilization of opioids consumed (consumed/prescribed)

Group	Value	95% CI
Standard of Care	26.7	± 0.91
Patient Directed Care	38.4	± 1.08

Opioid Pills Prescribed Secondary · preoperative visit

Number of opioids prescribed

Group	Value	95% CI
# Pills Prescribed Standard	30	30 – 30
# Pills Prescribed Patient Directed	15	12 – 24

Patient Satisfaction Secondary · 6 weeks post-operative

Patients were asked if they were satisfied with the # of oxycodone pills prescribed.

Group	Value	95% CI
Standard of Care	27
Patient Directed Care	29

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.