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Opioid Analgesic

Reduced Opioid Prescription for Postoperative Pain

N/A

Waitlist Available

Led By Mostafa Borahay

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Allergy or other contraindication to the prescribed medications such as acetaminophen, ibuprofen, or oxycodone

Conversion to laparotomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

No Placebo-Only Group

Summary

This trial studies safer opioid prescription after surgery to address the opioid epidemic.

Who is the study for?

This trial is for adults over 18 who are having outpatient laparoscopic hysterectomy for non-cancerous reasons. It's not open to those with allergies to acetaminophen, ibuprofen, or oxycodone, a recent history of opioid use or abuse, chronic pain conditions, if the surgery changes to an open procedure, or if they need to stay in the hospital overnight.

What is being tested?

The study is testing whether using lower doses of opioids like OxyCODONE (5 mg), combined with common pain relievers Acetaminophen (500 mg) and Ibuprofen (600 mg), can effectively manage pain after laparoscopic hysterectomy without leading to opioid misuse.

What are the potential side effects?

Possible side effects may include nausea, constipation from OxyCODONE; liver damage from too much Acetaminophen; and stomach upset or bleeding from Ibuprofen. Each person might react differently.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to acetaminophen, ibuprofen, or oxycodone.

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My surgery was changed to an open procedure.

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I am having surgery because of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Secondary study objectives

Mobility on postoperative day one

Mobility on postoperative day seven

Opioids

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Post-operative opioid prescriptionExperimental Treatment3 Interventions

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)

Group II: No Opioid prescriptionActive Control2 Interventions

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

OxyCODONE 5 mg Oral Tablet

2019

Completed Phase 4

~70

Ibuprofen 600 mg

2021

Completed Phase 4

~2630