Opioid Use After Laparoscopic Salpingectomy

Opioid Use Clinical Trial

Official title:

A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06434233
• Other study ID #: IRB00308549
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: Mostafa Borahay, MD
• Phone: 4439970400
• Email: mboraha1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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