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

NCT04933058 | Completed

• 1 other identifier: 1025-20-TLV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Women Undergoing Oocyte Retrieval Procedures

Outcome Measures

Primary Outcomes (2)

• the difference in average pain scores

  We will test the difference in average pain scores between the groups in a non-inferiority model. All pain scores obtained during the initial two postoperative hours will be averaged and compared between the groups. The non-inferiority delta will be defined a priori as no worse than 1.5 points in average pain score. Overall alpha will be 0.05. NRS Scale from 0-10, zero is no pain.

  1 year

• the dependent categorical variable of time-to-discharge readiness

  The secondary analysis will compare the dependent variable of time-to-discharge from postanesthesia care unit (PACU) readiness at 60 mins (yes/no) between the two study groups and will be reported as number (proportions). We will also record the time from arrival until discharge from PACU reported as the median \[interquartile range\] time in each group. Overall alpha will be 0.05.

  1 year

Other Outcomes (1)

• comparison of the average sedation scores 20 minutes after admission to the recovery room

  1 year

Study Arms (2)

Opioid-free anesthesia

EXPERIMENTAL

1. IV propofol 1-1.5 mg/kg 2. IV acetaminophen 1000mg 3. IV dipyrone 1000mg 4. IV lidocaine 1mg/kg 5. IV dexacort 4mg 6. PR diclofenac 50 mg

Drug: IV acetaminophen

Opioid-supplemented anesthesia

ACTIVE COMPARATOR

1. IV propofol 1-1.5 mg/kg 2. IV fentanyl 1.5 mcg/kg 3. IV dipyrone 1000mg 4. IV lidocaine 1mg/kg 5. IV dexacort 4mg 6. PR diclofenac 50 mg

Drug: IV fentanyl

Interventions

IV acetaminophen DRUG

Pain management

Opioid-free anesthesia

IV fentanyl DRUG

Pain management

Opioid-supplemented anesthesia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent
• years old
• American Society of Anesthesiologists (ASA) physical status 1-2
• Undergoing oocyte retrieval procedures
• Planned number of oocytes to be retrieved \<15

You may not qualify if:

• Known allergy to fentanyl, acetaminophen, dipyrone, lidocaine, propofol or NSAIDs.
• Endometriosis
• Diagnosis of chronic pain
• 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.
• Weight \< 50 kg
• Cannabis use
• Major psychiatric disorder - Schizophrenia, bipolar disorder, major depression.
• Epilepsy disorder under anti-convulsant therapy.
• Renal insufficiency, defined as creatinine clearance \<60 ml/hr
• Hepatic disease

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

tel aviv SMO

Tel Aviv, Israel

Location

MeSH Terms

Interventions

Acetaminophen; Fentanyl

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Elena Farladansky, MD

  senior doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 21, 2021
• Study Start: December 5, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)