A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy
Overview
- Phase
- Phase 4
- Intervention
- Acetaminophen
- Conditions
- Opioid Use
- Sponsor
- Johns Hopkins University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Numeric post-operative pain score
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
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
Arms & Interventions
Arm 1 - Opioid Post-Op Pain Regimen
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
Intervention: Acetaminophen
Arm 1 - Opioid Post-Op Pain Regimen
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
Intervention: Ibuprofen
Arm 1 - Opioid Post-Op Pain Regimen
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
Intervention: Oxycodone
Arm 2 - Non-Opioid Post-Op Pain Regimen
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.
Intervention: Acetaminophen
Arm 2 - Non-Opioid Post-Op Pain Regimen
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.
Intervention: Ibuprofen
Outcomes
Primary Outcomes
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
- 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)