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Clinical Trials/NCT06532708
NCT06532708
Recruiting
N/A

Prospective Study of Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery

University of Tennessee1 site in 1 country12 target enrollmentJuly 12, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Opioid Use
Sponsor
University of Tennessee
Enrollment
12
Locations
1
Primary Endpoint
Number of pills used
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 12, 2024
End Date
October 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 to 80
  • Undergoing planned laparoscopic hysterectomy as a day surgery procedure

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

Outcomes

Primary Outcomes

Number of pills used

Time Frame: Within 1 week following surgery

All participants will be contacted on postoperative days 2 and 7 to inquire how many pills they have taken

Secondary Outcomes

  • Postoperative pain(Within 2 weeks following surgery)

Study Sites (1)

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