Rectal Acetaminophen During Oocyte Retrievals

NCT05990868 | Unknown DMC

• 1 other identifier: STUDY005325
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Oocyte Retrieival and Post Operative Pain Control

Outcome Measures

Primary Outcomes (1)

• Evaluate reduction in opioid use post oocyte retrieval

  to determine the proportion of prescribed Acetaminophen and Opioids (oxycodone) used for the management of pain 3 days after egg retrieval.

  1 year

Study Arms (2)

Rectal tylenol group: Group 1

ACTIVE COMPARATOR

Randomization to the study group (Group 1): will receive standard anesthesia and 650 mg rectal Tylenol at the time of egg retrieval.

Drug: Tylenol

Placebo group: Group 2

PLACEBO COMPARATOR

Randomization to the standard of care group (Group 2): will receive standard anesthesia and rectal placebo at the time of oocyte retrieval. Placebo is a substance that has no therapeutic effect and used as a control in testing new drugs.

Drug: Tylenol

Interventions

Tylenol DRUG

Rectal tylenol will be placed at the time of oocyte retrieval

Placebo group: Group 2; Rectal tylenol group: Group 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only females can undergo oocyte retrieval as they are the gender with ovaries. Our study involves oocyte retrieval procedure.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Patients with chronic pain conditions such as fibromyalgia and sickle cell anemia.
• Patient with BMI greater than 40
• Patients undergoing transabdominal ultrasound guided oocyte retrieval
• Patients that required general endotracheal intubation anesthesia in prior oocyte retrieval.
• Patients with documented allergic reaction to acetaminophen or oxycodone
• Patient with contra-indication to the use of acetaminophen (liver disease)
• Patients with a history of past or current alcohol, drug or opioid abuse.
• Patients with ulcerative colitis, Crohn's disease, or severe rectal hemorrhoids.
• Patients who develop complication such as PID post procedure.

Sponsors & Collaborators

• University of South Florida: lead

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both patient and provider will be blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08