drugset / Trial / NCT04933058

Opioid Based Analgesia vs Non-opioid Analgesia for Oocyte Retrieval Procedure

NCT04933058 ↗

Completed 100 enrolled Tel-Aviv Sourasky Medical Center
RandomizedParallel-groupTriple-blindTreatment

Summary

It is unclear whether routine addition of opioids for analgesia during minor gynecological procedures is beneficial. In this single-center randomized single-blinded trial, the investigators aim to test the primary hypothesis that opioid-sparing anesthesia regimen including intravenous acetaminophen is non-inferior to a similar anesthesia regimen containing fentanyl in providing postoperative analgesia in women recovering from oocyte retrieval procedures for in vitro fertilization. The investigators also aim to assess the difference in incidence of patient-reported opioid related adverse-effects between the two groups, time to discharge from the post-anesthesia care unit and postoperative rescue analgesia requirements. If we demonstrate no clinically important difference between the two interventions, clinicians may be able to substantially reduce the amount of opioids administered to patients undergoing minor ambulatory procedures, and potentially decrease the associated opioid related adverse effects.

Timeline

Start
2021-12-05
Primary completion
2022-10-30
Completion
2022-10-30

Outcome

Met primary endpoint

paper Intra-operative IV paracetamol 1000 mg was non-inferior to fentanyl 100 μg for post-procedure analgesia PMID 40451048 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1000 mg Intravenous
Comparator Fentanyl Other / unclassified 1.5 ug/kg Intravenous