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

University of South Florida

Status and phase

Terminated

Phase 4

Conditions

Opioid Use

Treatments

Drug: Acetaminophen

Drug: Fentanyl

Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT03732469

00037883

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

Female

Ages

18 to 56 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

4 participants in 2 patient groups

Fentanyl/propofol + acetaminophen

Experimental group

Description:

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.

Treatment:

Drug: Fentanyl

Drug: Propofol

Drug: Acetaminophen

Fentanyl/propofol only

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl

Drug: Propofol