Opioid Use After Laparoscopic Salpingectomy

A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use; Post-operative Pain; Sterility, Female
• Intervention / Treatment: Drug: Acetaminophen; Drug: Ibuprofen; Drug: Oxycodone

Detailed Description

This study is designed as a non-inferiority trial comparing a non-opioid post-operative pain control regimen to the standard opioid pain control regimen for post-operative salpingectomy patients. A non-inferiority margin of 2 units was selected, such that the experimental treatment will be considered non-inferior if the lower bound of the confidence interval for the treatment difference remains above a 2 point difference in reported pain scores.

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mostafa Borahay, MD; Phone Number: 4439970400; Email: mboraha1@jhmi.edu
• Study Contact Backup: Name: Shannon Osborne, MD; Phone Number: 4105502786; Email: sosbor13@jh.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Bayview Medical Center
      • Contact: Mostafa Borahay, MD; Phone Number: 443-997-0400; Email: mboraha1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Acetaminophen; 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.; Other Names: Tylenol; Drug: Ibuprofen; 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.; Drug: Oxycodone; 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
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.	Drug: Acetaminophen; 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.; Other Names: Tylenol; Drug: Ibuprofen; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric post-operative pain score	Patient reported pain on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" using the Likert pain scale from 0 to 10, where 0 is no pain and 10 is severe pain. A higher score indicates a worse outcome.	post-operative day 1 and post-operative day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with post-operative pain relief	As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "Yes" indicates a favorable outcome and "no" indicates a worse outcome.	post-operative day 1 and post-operative day 7
Satisfaction with post-operative mobility	As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "Yes" indicates a favorable outcome and "no" indicates a worse outcome.	post-operative day 1 and post-operative day 7
Total narcotic consumption at one week post-operative	Number of Oxycodone pills used by each patient by the end of post-operative day 7	post-operative day 7
Occurrence of defined opioid related side effects (N/V, constipation, dizziness, itchiness)	As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "No" indicates a favorable outcome and "yes" indicates a worse outcome.	post-operative day 1 and post-operative day 7
Suboptimal pain control as assessed by the number of patients requesting additional medication or seeking unplanned medical care for a post-surgical pain-related concern	Number of patients who request additional pain medications at the time of post-operative surveys, call provider phone line for additional pain medications, or return to an Emergency Department, clinic/office, etc due to a pain related issue.	Within 30 days of surgery

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Mostafa Borahay, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Infertility, Female; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Heterocyclic Compounds, 4 or More Rings; Acids, Carbocyclic; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Codeine; Phenylpropionates; Acetaminophen; Ibuprofen; Oxycodone
• Other Study ID Numbers: IRB00308549

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No