Opioid Use, Post-operative Pain, Sterility, Female
Conditions
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.
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
DRUGAcetaminophen
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.
DRUGIbuprofen
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.
DRUGOxycodone
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
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric post-operative pain score | 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
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with post-operative pain relief | post-operative day 1 and post-operative day 7 | 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. |
| Satisfaction with post-operative mobility | post-operative day 1 and post-operative day 7 | 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. |
| Total narcotic consumption at one week post-operative | post-operative day 7 | Number of Oxycodone pills used by each patient by the end of 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 | 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. |
| 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 | 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. |
Countries
United States
Contacts
CONTACTMostafa Borahay, MD
CONTACTShannon Osborne, MD
PRINCIPAL_INVESTIGATORMostafa Borahay, MD
Johns Hopkins University
Outcome results
None listed