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NCT Number: NCT06434233

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.

Recruiting

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Key information

Conditions

Opioid Use Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Pain Postoperative Complications Signs and Symptoms Sterility, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location status: Recruiting

Location contact

Mostafa Borahay, MD

CONTACT

[email protected]

443-997-0400

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

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

Ibuprofen

Drug

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

Drug

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 outcomes

  1. Numeric post-operative pain score

    Time frame: post-operative day 1 and post-operative day 7

    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.

Secondary outcomes

  1. Satisfaction with post-operative pain relief

    Time frame: post-operative day 1 and post-operative day 7

    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.

  2. Satisfaction with post-operative mobility

    Time frame: post-operative day 1 and post-operative day 7

    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.

  3. Total narcotic consumption at one week post-operative

    Time frame: post-operative day 7

    Number of Oxycodone pills used by each patient by the end of post-operative day 7

  4. Occurrence of defined opioid related side effects (N/V, constipation, dizziness, itchiness)

    Time frame: post-operative day 1 and post-operative day 7

    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.

  5. 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

    Time frame: Within 30 days of surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa Borahay, MD

CONTACT

[email protected]

4439970400

Shannon Osborne, MD

CONTACT

[email protected]

4105502786

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 30, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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