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Opioid vs Non-Opioid Pain Management for Postoperative Pain

Baltimore, MD

N/A

Recruiting

Led By Mostafa Borahay, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure

Age 18 years old and above

Must not have

Salpingectomy performed for treatment of ectopic pregnancy

Patients currently on long-term (i.e. for more than three months) opioid use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days of surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare pain scores in patients undergoing minimally invasive tubal sterilization using a pain control regimen with opioids versus a regimen without opioids. The researchers believe that by providing detailed counseling and using

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Who is the study for?

This trial is for women who have undergone a minimally invasive procedure to remove their fallopian tubes (laparoscopic salpingectomy) and are experiencing post-operative pain. Participants should not currently be struggling with opioid misuse or have conditions that would interfere with the study.Check my eligibility

What is being tested?

The study is testing if a combination of non-opioid pain relievers like Acetaminophen and Ibuprofen can manage pain just as well as including an opioid (Oxycodone) in the treatment plan after tubal sterilization surgery.See study design

What are the potential side effects?

Possible side effects may include gastrointestinal issues such as stomach upset from Ibuprofen, liver damage risk from Acetaminophen, and addiction or respiratory problems from Oxycodone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having a laparoscopic or robotic surgery to remove my fallopian tubes.

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I am 18 years old or older.

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I am having my fallopian tubes removed for non-cancerous reasons.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had surgery to remove my fallopian tube due to an ectopic pregnancy.

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I have been using opioids for more than three months.

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My surgery was changed to an open procedure.

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I am not allergic to medications like acetaminophen or oxycodone.

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I had my fallopian tubes removed during a major gynecological surgery.

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I have a history of stomach inflammation or bleeding.

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I have a chronic pain condition like fibromyalgia.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Numeric post-operative pain score

Secondary study objectives

Occurrence of defined opioid related side effects (N/V, constipation, dizziness, itchiness)

Satisfaction with post-operative mobility

Satisfaction with post-operative pain relief

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 2 - Non-Opioid Post-Op Pain RegimenExperimental Treatment2 Interventions

Patients randomized to Arm 2 will not receive an opioid prescription after minimally invasive tubal sterilization procedures at discharge. They will receive only Tylenol and Ibuprofen as follows: Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter. Participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of oxycodone as in arm 1.

Group II: Arm 1 - Opioid Post-Op Pain RegimenActive Control3 Interventions

Patients randomized to Arm 1 will receive the current most commonly prescribed pain control regimen after a minimally invasive tubal sterilization procedure at discharge. These medications include: Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and Oxycodone 5 mg orally every 4 hours as needed x 12 tablets All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetaminophen

2017

Completed Phase 4

~2030

Ibuprofen

2013

Completed Phase 4

~5800