Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery

Last updated: July 31, 2024
Sponsor: University of Tennessee
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-surgical Pain

Acute Pain

Pain

Treatment

5x Oxycodone Oral Tablets

16x Oxycodone Oral Tablets

Clinical Study ID

NCT06532708
24-09978-FB
  • Ages 18-80
  • Female
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to compare opioid prescribing practices by either routine provider prescribing practices, or with the use of a calculator, i.e., the Opioid Calculator, published by the University of Michigan (www.opioidcalculator.org), with the intent of decreasing the number of pills.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women aged 18 to 80

  • Undergoing planned laparoscopic hysterectomy as a day surgery procedure

Exclusion

Exclusion Criteria:

  • Women aged 18 to 80

  • Undergoing a non-laparoscopic unplanned surgical procedure

  • Patients with a history of opioid use disorder or current opioid use disorder

Study Design

Total Participants: 12
Treatment Group(s): 2
Primary Treatment: 5x Oxycodone Oral Tablets
Phase:
Study Start date:
July 12, 2024
Estimated Completion Date:
October 31, 2024

Study Description

The intent of this study is to validate the use of the Opioid Calculator, published at University of Michigan (www.opioidcalculator.org), which takes several variables into account, including age, risk factors (history of depression, alcohol abuse, others) to determine in a more scientific way the number of pills sufficient to prescribe. The sample size was determined by the number of routine post-op laparoscopic patients seen in our practice. The estimated necessary sample size is 6 participants per group (12 total). Patients will be randomized using 3 block groups of size 4 each. Patients will be approached at in clinic at the time they are consenting to laparoscopic hysterectomy and will be counseled about postoperative pain medication management. Randomization to either standard practice or calculator will be performed using computer-generated, permuted blocks of 4 participants. Sealed randomization envelopes will be opened for each subject on the day of surgery, after anesthesia is initiated. The study will be singled-blinded to the participant. Patients will be contacted on day 2 and day 7 to inquire where they are on the Visual Analog Scale (VAS) and how many pills they have taken. Two weeks after surgery patients will be seen in office for VAS and requested to bring unused pills for accounting purposes.

Connect with a study center

  • University of Tennessee Health Science Center

    Memphis, Tennessee 38103
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.