RECRUITING

Opioid Use After Laparoscopic Salpingectomy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy

Quick Facts

Study Start:2024-04-25
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06434233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals with a fallopian tube (unilateral and/or bilateral)
  2. * Age 18 years old and above
  3. * Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure
  4. * Benign indications for salpingectomy/tubal sterilization
  5. * Agreeing to participate
  1. * Chronic pain syndromes patients including fibromyalgia
  2. * Patients currently on long-term (i.e. for more than three months) opioid use
  3. * Conversion to laparotomy
  4. * Allergy or other contraindication to the prescribed medications such as acetaminophen or oxycodone
  5. * Salpingectomy that occurs in conjunction with a major Gyn surgery (i.e. hysterectomy, etc)
  6. * Salpingectomy performed for treatment of ectopic pregnancy
  7. * Patients with a history of gastritis and/or GI bleeding

Contacts and Locations

Study Contact

Mostafa Borahay, MD
CONTACT
4439970400
mboraha1@jhmi.edu
Shannon Osborne, MD
CONTACT
4105502786
sosbor13@jh.edu

Principal Investigator

Mostafa Borahay, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Mostafa Borahay, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-25
Study Completion Date2025-06

Study Record Updates

Study Start Date2024-04-25
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use
  • Post-operative Pain
  • Sterility, Female