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Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription

NCT03588910 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-08-13

Study results available
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Summary

Currently there is a nationwide epidemic in opioid abuse and overdose deaths. While the opioid epidemic is multi-factorial one major source of excess opioids may be over-prescribing in the post-operative period. There is wide variation in the prescribing practices for post-operative pain control and there is no standard of care for pain control after minor laparoscopic surgery in general or after gynecologic laparoscopy. There is also evidence to show that on average half of the opioids prescribed are unused by the patient. The aim of the study is to evaluate two opioid prescription regimens.

Conditions

  • Surgery

Interventions

DRUG

Acetaminophen

50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)

DRUG

Ibuprofen 600 mg

25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)

DRUG

Oxycodone

The number of tablets of oxycodone prescribed is the only difference between the two arms.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Ja Hyun Shin, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-08
Primary Completion
2019-07-04
Completion
2019-08-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03588910 on ClinicalTrials.gov