Recruiting

Multimodal Pain Control

Sponsor:

Johns Hopkins University

Code:

NCT06434233

Conditions

Opioid Use

Post-operative Pain

Sterility, Female

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Acetaminophen

Ibuprofen

Oxycodone

Study Details

Brief 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.

Conditions

Opioid Use

Post-operative Pain

Sterility, Female

Study ID

NCT06434233

Start date

Apr 25, 2024

Status verified date

Jun, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

38 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

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

Primary outcome measure

  • Numeric post-operative pain score [ Time Frame: post-operative day 1 and post-operative day 7 ]

Central Contacts and Locations

Central contacts

Mostafa Borahay, MD

4439970400mboraha1@jhmi.edu

Shannon Osborne, MD

4105502786sosbor13@jh.edu

Locations

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Mostafa Borahay, MD

443-997-0400mboraha1@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-03.