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Opioid UsePhase 4NCT03732469

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

A Phase 4 study testing Acetaminophen, Fentanyl and Propofol in people with Opioid Use, run by University of South Florida at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 56 years, women onlyHealthy volunteers can take part
Conditions the study is for
Opioid Use
What is being tested?
Acetaminophen, Fentanyl and Propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
1 Nov 2019to 1 Mar 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 56 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • University of South Florida

    Tampa, Florida, 33606

Other trials in United States

About this study

Official title: Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients

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.

Read the 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
Keywords
egg retrieval, oocyte retrieval, opioid dependence, rectal acetaminophen, rectal tylenol, pain, opioid use, opioid abuse
Medical subject headings
Opioid-Related Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcetaminophenDrug

    Also called Tylenol

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

  • FentanylDrug

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

  • PropofolDrug

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

Study groups in NCT03732469
Study groupRoleWhat they receive
Fentanyl/propofol + acetaminophenExperimentalIn 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.
Receives: Drug: Acetaminophen; Drug: Fentanyl; Drug: Propofol
Fentanyl/propofol onlyActive comparatorParticipants in this arm will receive the weight-based intraoperative IV dose of propofol and fentanyl per standard TGH Anesthesiology protocol.
Receives: Drug: Fentanyl; Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 72 hours following oocyte retrieval

Secondary outcomes (4)

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

    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.

    Measured: 1-hour after oocyte retrieval

  2. 24-hour pain score using the Visual Analog Scale

    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.

    Measured: 24 hours after oocyte retrieval

  3. 48-hour pain score using the Visual Analog Scale measuring pain

    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.

    Measured: 48 hours after oocyte retrieval

  4. 72-hour pain score using the Visual Analog Scale measuring pain

    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.

    Measured: 72 hours after oocyte retrieval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2018
  2. Study start1 Nov 2019
  3. Primary completion31 Dec 2020
  4. Study completion1 Mar 2021

Why it stopped: Significant change in our clinic structure prevented continued recruitment of patients to the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03732469
Sponsor's protocol ID
00037883
Status last verified
Mar 2020
First submitted
31 Oct 2018
Last updated
18 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 9090556

  • 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.

    PubMed 20695152

  • 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.

    PubMed 28904501

  • 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.

    PubMed 15608039

  • 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.

    PubMed 29411339

  • 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.

    PubMed 27670651

  • 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.

    PubMed 28403427

  • 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.

    PubMed 1717195

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

    PubMed 15195324

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Acetaminophen, Fentanyl and Propofol in people with Opioid Use, run by University of South Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Significant change in our clinic structure prevented continued recruitment of patients to the study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of prescribed Tylenol with Codeine (Tylenol #3) utilized (time frame: 72 hours following oocyte retrieval). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03732469, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.

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