Opioid Use After Laparoscopic Salpingectomy
A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy
Johns Hopkins University
120 participants
Apr 25, 2024
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids. The study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy.
Eligibility
Inclusion Criteria5
- Individuals with a fallopian tube (unilateral and/or bilateral)
- Age 18 years old and above
- Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure
- Benign indications for salpingectomy/tubal sterilization
- Agreeing to participate
Exclusion Criteria7
- Chronic pain syndromes patients including fibromyalgia
- Patients currently on long-term (i.e. for more than three months) opioid use
- Conversion to laparotomy
- Allergy or other contraindication to the prescribed medications such as acetaminophen or oxycodone
- Salpingectomy that occurs in conjunction with a major Gyn surgery (i.e. hysterectomy, etc)
- Salpingectomy performed for treatment of ectopic pregnancy
- Patients with a history of gastritis and/or GI bleeding
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Interventions
All patients will receive Acetaminophen 500 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge. All patients will be instructed to take Acetaminophen around the clock for the first 72 hours and as needed thereafter.
All patients will receive Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge. All patients will be instructed to take Ibuprofen around the clock for the first 72 hours and as needed thereafter.
Patients randomized to Arm 1 will receive Oxycodone 5 mg orally every 4 hours as needed x 12 tablets at post-operative discharge Patients randomized to Arm 2 will not receive an Oxycodone prescription at post-operative discharge. However, 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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06434233