A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
Maryland
Johns Hopkins Bayview Medical Center
RECRUITING
Baltimore
Contact Information
Primary
Mostafa Borahay, MD
mboraha1@jhmi.edu
4439970400
Backup
Shannon Osborne, MD
sosbor13@jh.edu
4105502786
Time Frame
Start Date:2024-04-25
Estimated Completion Date:2026-01
Participants
Target number of participants:120
Treatments
Active_comparator: Arm 1 - Opioid Post-Op Pain Regimen
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
Experimental: Arm 2 - Non-Opioid Post-Op Pain Regimen
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.