Opioid Use After Laparoscopic Salpingectomy

Johns Hopkins University

Status: Enrolling

Conditions: Post-operative Pain; Sterility, Female; Opioid Use

Treatments: Drug: Oxycodone; Drug: Ibuprofen; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT06434233

IRB00308549

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Arm 1 - Opioid Post-Op Pain Regimen

Active Comparator group

Description:

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

Treatment:

Drug: Acetaminophen

Drug: Ibuprofen

Drug: Oxycodone

Arm 2 - Non-Opioid Post-Op Pain Regimen

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen

Drug: Ibuprofen