Clinical trial

Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients.

Name
STUDY005325
Description
As the opioid epidemic shows no sign of abating, this national crisis deserves careful attention from all medical subspecialties. This includes reproductive endocrinology and infertility (REI), where opioids are primarily utilized for intraoperative and postoperative pain management for outpatient procedures such as oocyte retrievals, operative hysteroscopy, and laparoscopic myomectomy. The primary aim of this study is to evaluate whether or not the administration of rectal acetaminophen as an alternative analgesic at the completion of oocyte retrieval would reduce postoperative utilization of opioids (Tylenol with oxycodone) in fertility patients. This trial has the potential to provide practice-changing clinical information to the field of REI. The information gained can even translate to other ambulatory procedures and guide clinical practice. Primary objective of the study will be to identify the proportion of prescribed Acetaminophen and Narcotics utilized 3 days following oocyte retrieval.
Trial arms
Trial start
2023-08-01
Estimated PCD
2024-08-01
Trial end
2025-08-01
Status
Not yet recruiting
Treatment
Tylenol
Rectal tylenol will be placed at the time of oocyte retrieval
Arms:
Placebo group: Group 2, Rectal tylenol group: Group 1
Size
78
Primary endpoint
Evaluate reduction in opioid use post oocyte retrieval
1 year
Eligibility criteria
Inclusion Criteria: Any female patient undergoing oocyte retrieval by transvaginal ultrasound-guided ovarian puncture. - Exclusion Criteria: 1. Patients with chronic pain conditions such as fibromyalgia and sickle cell anemia. 2. Patient with BMI greater than 40 3. Patients undergoing transabdominal ultrasound guided oocyte retrieval 4. Patients that required general endotracheal intubation anesthesia in prior oocyte retrieval. 5. Patients with documented allergic reaction to acetaminophen or oxycodone 6. Patient with contra-indication to the use of acetaminophen (liver disease) 7. Patients with a history of past or current alcohol, drug or opioid abuse. 8. Patients with ulcerative colitis, Crohn's disease, or severe rectal hemorrhoids. 9. Patients who develop complication such as PID post procedure. -
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The primary outcome in this study is the proportion of the prescribed medications used three days after discharge from the surgery. Assuming that only one third or less of the Narcotics prescribed (2 out of 6 tablets) in Group 1 will be utilized as compared to two thirds or more (4 out of 6 tables) in group 2, 35 patients in each group will be required to achieve 80% power and two-sided level of significance of 0.058. Given we expect possible 10% drop out rate after randomization, we plan to recruit 39 patients in each group (78 total sample). We plan to perform our analysis using SPSS.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Both patient and provider will be blinded to the intervention.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 78, 'type': 'ESTIMATED'}}
Updated at
2023-08-14

1 organization

1 product

1 indication

Product
Tylenol