CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
Acetaminophen +2 moredrug
Likely dose
Ibuprofen 600 mgfrom 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/NCT03588910
NCT03588910Phase 2Completed

Ambulatory Gynecologic Surgery: Finding the Optimal Postoperative Opioid Prescription

Montefiore Medical Center·interventional·Posted Jul 17, 2018·Updated Aug 13, 2021

In Brief

A Phase 2 clinical trial evaluating Acetaminophen, Ibuprofen 600 mg, and 1 other intervention for Surgery. Completed, enrolled 120 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 17, 2018
Enrollment StartAug 8, 2018
Primary CompletionJul 4, 2019
Study CompletionAug 4, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.0 years ago

Interventions

Acetaminophendrug

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

Ibuprofen 600 mgdrug

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

Oxycodonedrug

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