Opioid Use After Laparoscopic Salpingectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acetaminophen, Ibuprofen, Oxycodone.
- Who it may be relevant to
- Registry conditions: Opioid Use, Post-operative Pain, Sterility, Female. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy
Overview
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.
Detailed description
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.
Interventions
- 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. - Drug 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. - Drug 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 measures
- Numeric post-operative pain score [Time frame: post-operative day 1 and post-operative day 7]
Secondary outcome measures (5)
- Satisfaction with post-operative pain relief [Time frame: post-operative day 1 and post-operative day 7]
- Satisfaction with post-operative mobility [Time frame: post-operative day 1 and post-operative day 7]
- Total narcotic consumption at one week post-operative [Time frame: post-operative day 7]
- Occurrence of defined opioid related side effects (N/V, constipation, dizziness, itchiness) [Time frame: 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 [Time frame: Within 30 days of surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Johns Hopkins Bayview Medical Center — Baltimore
Identifiers
NCT: NCT06434233 · IRB00308549