Opioid Use After Laparoscopic Salpingectomy

NCT06434233 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00308549
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Satisfaction with post-operative pain relief

  post-operative day 1 and post-operative day 7

• Satisfaction with post-operative mobility

  post-operative day 1 and post-operative day 7

• Total narcotic consumption at one week post-operative

  post-operative day 7

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

  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

  Within 30 days of surgery

Study Arms (2)

Arm 1 - Opioid Post-Op Pain Regimen

ACTIVE COMPARATOR

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; Drug: Ibuprofen; Drug: Oxycodone

Arm 2 - Non-Opioid Post-Op Pain Regimen

EXPERIMENTAL

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; Drug: Ibuprofen

Interventions

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.

Also known as: Tylenol

Arm 1 - Opioid Post-Op Pain Regimen; Arm 2 - Non-Opioid Post-Op Pain Regimen

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.

Arm 1 - Opioid Post-Op Pain Regimen; Arm 2 - Non-Opioid Post-Op Pain Regimen

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

Arm 1 - Opioid Post-Op Pain Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Infertility, Female

Interventions

Acetaminophen; Ibuprofen; Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Mostafa Borahay, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Borahay, MD

CONTACT

4439970400; mboraha1@jhmi.edu

Shannon Osborne, MD

CONTACT

4105502786; sosbor13@jh.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: April 25, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)