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.
Study Overview The investigators propose a single-center randomized single-blinded clinical trial in which healthy women undergoing oocyte retrieval procedures under general anesthesia will be randomized to receive either 1.5mcg/kg fentanyl or IV acetaminophen as part of multimodal analgesia. The investigators will evaluate the effects of an opioid-free anesthesia on pain scores, analgesic medication consumption during the initial two postoperative hours, and time to discharge from PACU, compared to an opioid-containing anesthesia.The investigators will also compare the prevalence of opioid-related sedation side effect between opioid-free anesthesia and opioid-containing anesthesia.
Setting and Population Inclusion Criteria
Withdrawal Criteria
an allergic reaction, analgesic failure per acute pain service judgement and significant patient discomfort.
3. Reason for exclusion will be documented, and patients will be asked to continue follow-up according to the intention-to-treat principle
Protocol
The investigators propose a randomized, single-blinded single-center clinical trial. After confirming eligibility, patients will be approached before the procedure for possible enrollment in the study. After thorough explanation, written informed consent will be obtained. Patients will be randomized in a 1:1 ratio by a web-based software to receive
The anesthesiologist performing the procedure will not be blinded to group allocation, but other research team members and caregivers who evaluate the patients after the procedure will be.
General anesthesia will be induced according to the group allocation as mentioned above. Anesthesia maintenance will be achieved with 50% N2O via a face-mask, and additional doses of 10-20 mg of propofol as needed. Ketamine will not be allowed. Postoperatively, intravenous tramadol 100 mg will be ordered for breakthrough pain as well as intravenous ondansetron 4mg and metoclopramide 10mg for nausea and vomiting. Patients will be followed until home discharge. The rest of postoperative care will be conducted according to standard departmental procedures by nurses and physicians.
Measurements
Sample Size Considerations To test a unilateral non-inferiority hypothesis, assuming a 2.5% significance level, power of 80%, standard deviation of 2 points, a non-inferiority delta of no more than 1.5 points in the 11-point NRS pain scale between the two groups, and assumed pooled variance of 6, we will need a sample size of 42 patients in each group. Accounting for a predicted loss to follow-up of up to 20% of patients, we aim to recruit 100 patients.
Condition | Women Undergoing Oocyte Retrieval Procedures |
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Treatment | IV acetaminophen, IV Fentanyl |
Clinical Study Identifier | NCT04933058 |
Sponsor | Tel-Aviv Sourasky Medical Center |
Last Modified on | 17 December 2021 |
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