Reduced Opioid Prescription for Postoperative Pain

Recruiting in Palo Alto (17 mi)

Overseen by Mostafa Borahay, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mostafa Borahay, MD, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 and having a laparoscopic hysterectomy for non-cancer reasons.

Exclusion Criteria

You have used or abused opioids within the last 3 months.

People with long-term pain.

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

Treatment Details

Interventions

• Acetaminophen (Analgesic)
• Ibuprofen (Nonsteroidal Anti-inflammatory Drug)
• OxyCODONE (Opioid Analgesic)

Trial Overview 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.

Participant Groups

Group I: Post-operative opioid prescription Experimental Treatment 3 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 prescription Active Control 2 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)

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution