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

Sponsor
University of South Florida (Other)
Overall Status
Terminated
CT.gov ID
NCT03732469
Collaborator
(none)
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Study Details

Study Description

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
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
4 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
Actual Study Start Date :
Nov 1, 2019
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of South Florida Tampa Florida United States 33606

    Sponsors and Collaborators

    • University of South Florida

    Investigators

    • Principal Investigator: Anthony Imudia, MD, University of South Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of South Florida
    ClinicalTrials.gov Identifier:
    NCT03732469
    Other Study ID Numbers:
    • 00037883
    First Posted:
    Nov 6, 2018
    Last Update Posted:
    Jun 18, 2021
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 18, 2021