Reduced Opioid Prescription After Laparoscopic Hysterectomy

January 9, 2026 updated by: Johns Hopkins University

A Randomized Controlled Trial to Study Reduced Opioid Prescription After Laparoscopic Hysterectomy

Given the nationwide epidemic of opioid use and abuse (in part due to over prescription), this study aims at addressing the need for opioid prescription after laparoscopic hysterectomy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. Given the increasing opioid abuse and over-prescription post-operatively, an effort must be made to determine whether non-opioid multimodal medications are adequate in treating postoperative pain after laparoscopic hysterectomy and would not increase the need for additional prescriptions or unscheduled patient contacts. This study aims to find the optimal prescriptions for pain after laparoscopic hysterectomy in an attempt to eliminate opioid use.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients over the age of 18 undergoing outpatient laparoscopic (conventional or robotic) hysterectomy for benign indications

Exclusion Criteria:

  • Allergy or other contraindication to the prescribed medications such as acetaminophen, ibuprofen, or oxycodone
  • Known opioid use or abuse (defined as reported use or treatment for abuse within the last 3 months)
  • Chronic pain patients
  • Conversion to laparotomy
  • Malignancy as the indication for surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Post-operative opioid prescription

Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, then will receive Meloxicam 15mg daily x 48 hours then as needed

Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets)

Oxycodone 5mg every 4 hours as needed (total 12 tablets)
Drug: OxyCODONE 5 mg Oral Tablet
No opioid prescription after laparoscopic hysterectomy
Drug: Ibuprofen 600 mg
Standard prescription
Drug: Acetaminophen 500 mg Tab
Standard prescription
Active Comparator: No Opioid prescription

Ibuprofen 600mg every 6 hours x 48 hours then as needed (total 30 tablets). If allergy or contraindication to ibuprofen, will receive Meloxicam 15mg daily x 48 hours then as needed

Acetaminophen 500mg every 6 hours x 48 hours then as needed (total 30 tablets)
Drug: Ibuprofen 600 mg
Standard prescription
Drug: Acetaminophen 500 mg Tab
Standard prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score on post-operative day one
Time Frame: 1 day
Numeric pain score on post-operative day one: patient reported pain using the Likert pain scale from 0 to 10
1 day
Pain score on post-operative day seven
Time Frame: 7 days
Numeric pain score on post-operative day seven: patient reported pain using the Likert pain scale from 0 to 10
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction of pain control on postoperative day one
Time Frame: 1 day
Overall satisfaction of pain control on postoperative day one (binary question - Yes/No)
1 day
Satisfaction of pain control on postoperative day seven
Time Frame: 7 days
Overall satisfaction of pain control on postoperative day seven (binary question - Yes/No)
7 days
Mobility on postoperative day one
Time Frame: 1 day
Satisfaction with mobility on postoperative day one (binary question - Yes/No)
1 day
Mobility on postoperative day seven
Time Frame: 7 days
Satisfaction with mobility on postoperative day seven (binary question - Yes/No)
7 days
Total opioid consumption on postoperative day one
Time Frame: 1 day
Total narcotic consumption by postoperative day one (in morphine milligram equivalent)
1 day
Total opioid consumption on postoperative day seven
Time Frame: 7 days
Total narcotic consumption by postoperative day seven (in morphine milligram equivalent)
7 days
Opioid related side effects on postoperative day one
Time Frame: 1 day
Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day one (binary question - Yes/No)
1 day
Opioid related side effects on postoperative day seven
Time Frame: 7 days
Presence of opioid related side effects such as nausea, vomiting, constipation, dizziness, abdominal distention, and itchiness on postoperative day seven (binary question - Yes/No)
7 days
Unplanned calls/visits
Time Frame: 7 days
Unplanned visits to the emergency room or clinic and unexpected patient initiated phone call related to pain control postoperatively (binary question - Yes/No)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Mostafa Borahay, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 16, 2022

First Submitted That Met QC Criteria

September 16, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00345074

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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