Opioid Use Clinical Trial
Official title:
A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy
NCT number | NCT06434233 |
Other study ID # | IRB00308549 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 25, 2024 |
Est. completion date | June 2025 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Bayview Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
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 |
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