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

NCT03732469 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: 00037883
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use

Keywords

egg retrieval; oocyte retrieval; opioid dependence; rectal acetaminophen; rectal tylenol; pain; opioid use; opioid abuse

Outcome Measures

Primary Outcomes (1)

• Proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized

  The proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized 72 hours postoperatively will be assessed by telephone encounter. A total of 10 tablets of Tylenol #3 will be prescribed to each participant. Fewer Tylenol #3 used at the end of this time frame would indicate better outcome.

  72 hours following oocyte retrieval

Secondary Outcomes (4)

• Pain score in post-anesthesia care unit using the Visual Analog Scale

  1-hour after oocyte retrieval

• 24-hour pain score using the Visual Analog Scale

  24 hours after oocyte retrieval

• 48-hour pain score using the Visual Analog Scale measuring pain

  48 hours after oocyte retrieval

• 72-hour pain score using the Visual Analog Scale measuring pain

  72 hours after oocyte retrieval

Study Arms (2)

Fentanyl/propofol + acetaminophen

EXPERIMENTAL

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.

Drug: Acetaminophen; Drug: Fentanyl; Drug: Propofol

Fentanyl/propofol only

ACTIVE COMPARATOR

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

Drug: Fentanyl; Drug: Propofol

Interventions

Acetaminophen DRUG

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

Also known as: Tylenol

Fentanyl/propofol + acetaminophen

Fentanyl DRUG

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

Fentanyl/propofol + acetaminophen; Fentanyl/propofol only

Propofol DRUG

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

Fentanyl/propofol + acetaminophen; Fentanyl/propofol only

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33606, United States

Location

Related Publications (9)

• Ditkoff EC, Plumb J, Selick A, Sauer MV. Anesthesia practices in the United States common to in vitro fertilization (IVF) centers. J Assist Reprod Genet. 1997 Mar;14(3):145-7. doi: 10.1007/BF02766130.

  PMID: 9090556 BACKGROUND

• Fiebai PO, Ogunmokun AA, Ajayi RA. Experience with conscious sedation for oocyte retrieval in Nigeria. Afr J Reprod Health. 2008 Apr;12(1):30-4.

  PMID: 20695152 BACKGROUND

• Singhal H, Premkumar PS, Chandy A, Kunjummen AT, Kamath MS. Patient Experience with Conscious Sedation as a Method of Pain Relief for Transvaginal Oocyte Retrieval: A Cross Sectional Study. J Hum Reprod Sci. 2017 Apr-Jun;10(2):119-123. doi: 10.4103/jhrs.JHRS_113_16.

  PMID: 28904501 BACKGROUND

• Gejervall AL, Stener-Victorin E, Moller A, Janson PO, Werner C, Bergh C. Electro-acupuncture versus conventional analgesia: a comparison of pain levels during oocyte aspiration and patients' experiences of well-being after surgery. Hum Reprod. 2005 Mar;20(3):728-35. doi: 10.1093/humrep/deh665. Epub 2004 Dec 17.

  PMID: 15608039 BACKGROUND

• Ozaltin S, Kumbasar S, Savan K. Evaluation of complications developing during and after transvaginal ultrasound - guided oocyte retrieval. Ginekol Pol. 2018;89(1):1-6. doi: 10.5603/GP.a2018.0001.

  PMID: 29411339 BACKGROUND

• Frederiksen Y, Mehlsen MY, Matthiesen SM, Zachariae R, Ingerslev HJ. Predictors of pain during oocyte retrieval. J Psychosom Obstet Gynaecol. 2017 Mar;38(1):21-29. doi: 10.1080/0167482X.2016.1235558. Epub 2016 Sep 27.

  PMID: 27670651 BACKGROUND

• Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.

  PMID: 28403427 BACKGROUND

• van Hoogdalem E, de Boer AG, Breimer DD. Pharmacokinetics of rectal drug administration, Part I. General considerations and clinical applications of centrally acting drugs. Clin Pharmacokinet. 1991 Jul;21(1):11-26. doi: 10.2165/00003088-199121010-00002.

  PMID: 1717195 BACKGROUND

• Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.

  PMID: 15195324 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Pain

Interventions

Acetaminophen; Fentanyl; Propofol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Anthony Imudia, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 6, 2018
• Study Start: November 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: March 1, 2021
• Last Updated: June 18, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)