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Opioid Analgesic

Reduced Opioid Prescription for Postoperative Pain

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain

Secondary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,260 Previous Clinical Trials

14,820,660 Total Patients Enrolled

21 Trials studying Pain

2,297 Patients Enrolled for Pain

Mostafa BorahayPrincipal InvestigatorJohns Hopkins University

Media Library

Pain Research Study Groups: Post-operative opioid prescription, No Opioid prescription

Pain Clinical Trial 2023: OxyCODONE Highlights & Side Effects. Trial Name: NCT05548582 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current quota of participants for this clinical trial?

"Affirmative. Clinicaltrials.gov conveys that the trial is actively recruiting participants, with its first listing having been published on December 1st 2023 and most recently updated a day later. 120 individuals are needed for enrollment at one particular clinical site."

Answered by AI

What benefits are researchers looking to uncover from this trial?

"The primary metric of this 7-day study is a patient's Pain Score on the first postoperative day. Additionally, there are three secondary outcomes to track: Satisfaction with pain control on Day Seven (Yes/No), Mobility satisfaction on Day One (Yes/No) and any unplanned calls or visits due to poor pain management (Yes/No)."

Answered by AI

Have recruitment efforts for this investigation been initiated yet?

"Affirmative, the information on clinicaltrials.gov denotes that this medical experiment is presently in search of volunteers. This project was first uploaded to the platform during January 12th 2023 and has been updated as recently as December 1st 2023. A total of 120 patients are required for enrollment at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reduced Opioid Prescription After Laparoscopic Hysterectomy

2023. "Reduced Opioid Prescription After Laparoscopic Hysterectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05548582.