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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03732469
• Other study ID #: 00037883
• Status: Terminated
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2020
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 56 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use

Intervention

Drug:
• Acetaminophen
Rectal acetaminophen will be administered to the intervention group at the conclusion of the oocyte retrieval.
• Fentanyl
Weight-based IV Fentanyl as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital
• Propofol
Weight-based IV Propofol as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. Erratum in: JAMA Surg. 2019 Mar 1;154(3):272. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Gejervall AL, Stener-Victorin E, Möller 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. Epub 2004 Dec 17. — View Citation

Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. Review. — View Citation

Özaltin 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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1-hour after oocyte retrieval
Secondary	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.	24 hours after oocyte retrieval
Secondary	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.	48 hours after oocyte retrieval
Secondary	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.	72 hours after oocyte retrieval