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Opioid vs Non-Opioid Pain Management for Postoperative Pain

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

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

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.
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.
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.

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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numeric post-operative pain score
Secondary outcome measures
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

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

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,789 Total Patients Enrolled
Mostafa Borahay, MDPrincipal InvestigatorJohns Hopkins University
~70 spots leftby May 2025
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