Reduced Opioid Prescription for Postoperative Pain

Overseen By Marie-Claire Leaf, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Opioids

Disqualifiers: Opioid use, Chronic pain, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

120 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a known opioid use or abuse history, you may not be eligible to participate.

What data supports the effectiveness of the drug for reducing postoperative pain?

Research shows that oxycodone, an opioid included in the treatment, is effective for managing acute postoperative pain. However, caution is advised due to the risk of misuse and overdose. ^{1 2 3 4 5}

Is oxycodone safe for postoperative pain management?

Oxycodone is commonly used for postoperative pain relief, but it can cause side effects. Studies show that combining oxycodone with other pain relievers like acetaminophen can increase the risk of adverse events compared to taking a placebo. ^{1 3 6 7 8}

How is the drug Oxycodone unique for postoperative pain management?

Oxycodone is an opioid used for managing acute postoperative pain, and this trial explores reducing the number of pills prescribed to minimize overuse. This approach is part of a broader effort to address the opioid epidemic by limiting opioid prescriptions and considering non-opioid alternatives for pain control. ^{1 2 9 10 11}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive postoperative pain management with either opioid or non-opioid medications after laparoscopic hysterectomy

1 week

Postoperative day 1 and day 7 assessments

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction of pain control after treatment

1 week

Unplanned visits and calls monitored

Treatment Details

Interventions

• Acetaminophen
• Ibuprofen
• OxyCODONE

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+

Findings from Research

Oral oxycodone is effective for managing acute postoperative pain, showing superior analgesic efficacy compared to placebo and comparable or better pain relief than intravenous opioids in various surgical procedures, including knee arthroplasty and laparoscopic surgeries.

Patients using oral oxycodone experienced fewer side effects than those on other opioids, did not have prolonged hospital stays, and had lower overall drug costs, making it a safe and reasonable alternative for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Oxycodone for Acute Postoperative Pain: A Review of Clinical Trials. Cheung, CW., Ching Wong, SS., Qiu, Q., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Oral Oxycodone for Acute Postoperative Pain: A Review of Clinical Trials. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Postoperative Restrictive Opioid Protocols and Durable Changes in Opioid Prescribing and Chronic Opioid Use. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Oxycodone for the treatment of postoperative pain. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Impact of pharmacists assisting with prescribing and undertaking medication review on oxycodone prescribing and supply for patients discharged from surgical wards. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Opiate overdose in an adolescent after a dental procedure: a case report. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of dual-opioid therapy in acute pain. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Tapentadol Versus Oxycodone for Opioid-Related Adverse Drug Events and Clinical Outcomes After Inpatient Surgery. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Single dose oral oxycodone and oxycodone plus paracetamol (acetaminophen) for acute postoperative pain in adults. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

How low can you go: Achieving postoperative outpatient pain control without opioids. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Association of Opioid Prescribing With Opioid Consumption After Surgery in Michigan. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Examining Reduced Opioid Prescriptions after Gynecologic Laparoscopy: A Randomized Controlled Trial. [2021]