Rectal Acetaminophen Use During Oocyte Retrievals to Reduce Post-Operative Opioid Utilization

NCT ID: NCT03732469

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-03-01

Brief Summary

The primary aim of this study is to evaluate the administration of rectal acetaminophen to current and standard anesthesia and analgesia protocol in oocyte retrievals would reduce postoperative utilization of opioids (Tylenol with codeine) in fertility patients.

Detailed 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 purpose of this study is to evaluate whether the administration of rectal acetaminophen in addition to the current, standard anesthesia and analgesia protocol in oocyte retrievals can help decrease utilization of prescribed opioid at home following oocyte retrieval. Rectal acetaminophen will be used rather than conventional IV acetaminophen because of the lack of access to IV acetaminophen at the study institution. Rectal acetaminophen is appealing because it is cheap, readily available in most medical centers and there is the potential for increased analgesic benefit due to the proximity to the vaginal and ovarian tissue, as well as the possible benefit from the partial avoidance of hepatic first-pass metabolism. 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. The investigators hypothesize that participants given rectal acetaminophen in addition to standard anesthesia/analgesia at the end of their oocyte retrieval will use less amount of prescribed Tylenol with codeine 3 days after discharge from the surgery center compared those receiving standard anesthesia/analgesia for oocyte retrieval.

Conditions

Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Fentanyl/propofol + acetaminophen

In addition to the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol, one dose of 1300 mg of solid base rectal acetaminophen suppository (2 suppositories) will be administered at the end of oocyte retrieval.

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

Rectal acetaminophen will be administered to the intervention group at the conclusion of the oocyte retrieval.

Fentanyl

Intervention Type: DRUG

Weight-based IV Fentanyl as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital

Propofol

Intervention Type: DRUG

Weight-based IV Propofol as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital

Fentanyl/propofol only

Participants in this arm will receive the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol.

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

Weight-based IV Fentanyl as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital

Propofol

Intervention Type: DRUG

Weight-based IV Propofol as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital

Interventions

Acetaminophen

Rectal acetaminophen will be administered to the intervention group at the conclusion of the oocyte retrieval.

Intervention Type: DRUG

Fentanyl

Weight-based IV Fentanyl as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital

Intervention Type: DRUG

Propofol

Weight-based IV Propofol as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital

Intervention Type: DRUG

Other Intervention Names

Tylenol

Eligibility Criteria

Inclusion Criteria

• Any female patient undergoing oocyte retrieval by transvaginal ultrasound-guided ovarian puncture

Exclusion Criteria

• Patients with chronic pain conditions such as fibromyalgia and sickle cell anemia.
• Patient with BMI greater than 40
• Patients that required general endotracheal intubation anesthesia in prior oocyte retrieval
• Patients with documented allergic reaction to acetaminophen
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 56 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Imudia, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

University of South Florida

Tampa, Florida, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Other Identifiers

00037883

Identifier Type: -

Identifier Source: org_study_id