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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

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.
Select...
My surgery was changed to an open procedure.
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I am having surgery because of cancer.

Timeline

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
Pain
Secondary study objectives
Mobility on postoperative day one
Mobility on postoperative day seven
Opioids
+6 more

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

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,789 Total Patients Enrolled
1 Trials studying Opioid Abuse
12 Patients Enrolled for Opioid Abuse
Mostafa BorahayPrincipal InvestigatorJohns Hopkins University

Media Library

Opioid Abuse Research Study Groups: Post-operative opioid prescription, No Opioid prescription
Opioid Abuse Clinical Trial 2023: OxyCODONE Highlights & Side Effects. Trial Name: NCT05548582 — N/A
~16 spots leftby Dec 2024
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