Opioid Based Analgesia vs Non-opioid Analgesia for Oocyte Retrieval Procedure - a Randomized Clinical Trial

1025-20-TLV

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.

2021-12-05

2022-10-30

2022-10-30

Completed

100

Inclusion Criteria: 1. Written informed consent 2. 18-45 years old 3. American Society of Anesthesiologists (ASA) physical status 1-2 4. Undergoing oocyte retrieval procedures 5. Planned number of oocytes to be retrieved \<15 Exclusion Criteria: 1. Known allergy to fentanyl, acetaminophen, dipyrone, lidocaine, propofol or NSAIDs. 2. Endometriosis 3. Diagnosis of chronic pain 4. Opioid dependency, defined by consumption of oral morphine equivalent of greater than or equal to 60mg a day for 7 days or longer, for any time period. 5. Weight \< 50 kg 6. Cannabis use 7. Major psychiatric disorder - Schizophrenia, bipolar disorder, major depression. 8. Epilepsy disorder under anti-convulsant therapy. 9. Renal insufficiency, defined as creatinine clearance \<60 ml/hr 10. Hepatic disease

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2023-03-29