Opioid Use After Laparoscopic Salpingectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Acetaminophen
DrugAll 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.
Ibuprofen
DrugAll 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.
Oxycodone
DrugPatients 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
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: Arm 1 - Opioid Post-Op Pain RegimenActive comparator 3 interventions
Group B: Arm 2 - Non-Opioid Post-Op Pain RegimenExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
post-operative day 1 and post-operative day 7Secondary outcomes
1
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.
Time frame
post-operative day 1 and post-operative day 72
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.
Time frame
post-operative day 1 and post-operative day 73
Total narcotic consumption at one week post-operative
Number of Oxycodone pills used by each patient by the end of post-operative day 7
Time frame
post-operative day 74
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.
Time frame
post-operative day 1 and post-operative day 7Sponsors and contacts
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Source ClinicalTrials.gov