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

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ClinicalTrials.gov Identifier: NCT03732469
Recruitment Status : Not yet recruiting
First Posted : November 6, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of South Florida

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.

Condition or disease Intervention/treatment Phase
Opioid Use Drug: Acetaminophen Drug: Fentanyl Drug: Propofol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Acetaminophen
Rectal acetaminophen will be administered to the intervention group at the conclusion of the oocyte retrieval.
Other Name: Tylenol

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

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

Active Comparator: Fentanyl/propofol only
Participants in this arm will receive the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol.
Drug: Fentanyl
Weight-based IV Fentanyl as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital

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




Primary Outcome Measures :
  1. Proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized [ Time Frame: 72 hours following oocyte retrieval ]
    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.


Secondary Outcome Measures :
  1. Pain score in post-anesthesia care unit using the Visual Analog Scale [ Time Frame: 1-hour after oocyte retrieval ]
    The Visual Analog Scale will be used to assess postoperative pain 1-hour after egg retrieval. The scale will be in a range from 0 to 10, with 0 being no pain and 10 being unbearable pain. A lower score would indicate a better outcome.

  2. 24-hour pain score using the Visual Analog Scale [ Time Frame: 24 hours after oocyte retrieval ]
    The Visual Analog Scale will be used to assess pain 24 hours after egg retrieval. The scale will be in a range from 0 to 10, with 0 being no pain and 10 being unbearable pain. A lower score would indicate a better outcome.

  3. 48-hour pain score using the Visual Analog Scale measuring pain [ Time Frame: 48 hours after oocyte retrieval ]
    The Visual Analog Scale will be used to assess pain 48 hours after egg retrieval. The scale will be in a range from 0 to 10, with 0 being no pain and 10 being unbearable pain. A lower score would indicate a better outcome.

  4. 72-hour pain score using the Visual Analog Scale measuring pain [ Time Frame: 72 hours after oocyte retrieval ]
    The Visual Analog Scale will be used to assess pain 72 hours after egg retrieval. The scale will be in a range from 0 to 10, with 0 being no pain and 10 being unbearable pain. A lower score would indicate a better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 56 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732469


Contacts
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Contact: Clarissa Lam, MD 6463792934 clarissalam@health.usf.edu

Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Anthony Imudia, MD University of South Florida

Publications:

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03732469     History of Changes
Other Study ID Numbers: 00037883
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of South Florida:
egg retrieval
oocyte retrieval
opioid dependence
rectal acetaminophen
rectal tylenol
pain
opioid use
opioid abuse
Additional relevant MeSH terms:
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Acetaminophen
Fentanyl
Analgesics, Opioid
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Analgesics, Non-Narcotic
Antipyretics