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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to reduce opioid prescriptions for pain after laparoscopic hysterectomy, a common surgery to remove the uterus. Researchers are testing whether pain can be managed effectively with fewer opioids by comparing two groups: one receives a small amount of oxycodone (an opioid pain medication) along with ibuprofen and acetaminophen, while the other uses only ibuprofen and acetaminophen. This study targets patients undergoing laparoscopic hysterectomy for non-cancerous reasons. Participants should not have a history of opioid use or chronic pain. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance pain management strategies for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that oxycodone is a strong painkiller, particularly useful after surgery. In several studies, oxycodone relieved pain more effectively than a sugar pill (placebo). However, like other pain medications, it carries risks. Some studies found that oxycodone can cause side effects such as nausea, dizziness, or drowsiness. Despite these potential issues, when used correctly, oxycodone can effectively manage post-surgical pain. Following the directions is crucial to minimize the risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores ways to manage postoperative pain with fewer opioids. Unlike traditional methods that often rely heavily on opioids like oxycodone, this approach emphasizes alternative pain management strategies, such as using ibuprofen and acetaminophen as primary treatments. This trial could potentially reduce the risk of opioid dependency and side effects associated with their use, offering a safer, more balanced approach to pain management after surgery.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

This trial will compare two approaches to postoperative pain management: one arm will include a postoperative opioid prescription with oxycodone, while the other arm will not include opioids. Studies have shown that oxycodone is a strong painkiller that targets specific areas in the brain to reduce pain. However, research suggests it may not always be more effective than a combination of acetaminophen and codeine for pain relief in the first week after surgery. While oxycodone effectively manages severe pain, it requires careful use due to possible side effects, especially for individuals with kidney problems. The CDC provides guidelines for prescribing opioids like oxycodone to help reduce risks. Overall, while oxycodone is effective for severe pain, cautious use is necessary to avoid overuse and dependence. ^{6 7 8 9 10}

Who Is on the Research Team?

Mostafa Borahay, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. cdc.gov cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

CDC Clinical Practice Guideline for Prescribing Opioids ... This guideline provides recommendations for clinicians providing pain care, including those prescribing opioids, for outpatients aged ≥18 years.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482226/

Oxycodone - StatPearls - NCBI Bookshelf - NIH Oxycodone is a potent semisynthetic opioid agonist prescription medication with agonistic properties on mu-, kappa-, and delta-type opioid receptors.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0007091222003142

No place for routine use of modified-release opioids in ... Modified-release opioid tablets were introduced into surgical practice in the belief that they provided superior pain relief and reduced nursing workload, ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2786200

Effectiveness of Oxycodone Hydrochloride (Strong Opioid) ... This study found that oxycodone did not provide superior pain relief compared with combination acetaminophen and codeine during the first 7 days of treatment.

5. mdanderson.org mdanderson.org/documents/for-physicians/algorithms/clinical-management/clin-management-post-op-pain-web-algorithm.pdf

Peri-Operative Pain Management Codeine, morphine, hydromorphone, and oxycodone should be used with caution in patients with decreased renal function. ○ Opioids NOT recommended for cancer ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4170904/

Single dose oral oxycodone and oxycodone plus paracetamol ... Single dose oxycodone is an effective analgesic in acute postoperative pain at doses over 5 mg; oxycodone is two to three times stronger than codeine.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2950553424000248

Treatment-emergent adverse events of tapentadol or ... These findings suggest that tapentadol is a safer choice than oxycodone, exhibiting a lower incidence of TEAEs, particularly at minimum doses.

8. painphysicianjournal.com painphysicianjournal.com/current/pdf?article=NDIxMA==&journal=103

Oral Oxycodone for Acute Postoperative Pain Results: There were 26 clinical trials included in the review. Oral oxycodone showed superior postoperative analgesic efficacy compared with placebo in ...

9. link.springer.com link.springer.com/article/10.1007/s40122-019-0122-4

A Systematic Review of Randomized Controlled Trials Two studies reported significantly better postoperative pain relief with oxycodone ... In two studies, safety outcomes were comparable between ...

10. dovepress.com dovepress.com/effect-of-oxycodone-based-multimodal-analgesia-on-visceral-pain-after--peer-reviewed-fulltext-article-DDDT

Oxycodone- vs sufentanil-based multimodal analgesia Oxycodone-based multimodal analgesia reduced postoperative visceral pain in a statistically significant but not clinically important manner.