NCT06532708

Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery

Prospective Study of Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Tennessee · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid Use
• Postoperative Pain

Interventions

Type	Name	Description
OTHER	5x Oxycodone Oral Tablets	Participants will be prescribed 5 doses of 5mg tablets of oxycodone for postoperative pain relief.
OTHER	16x Oxycodone Oral Tablets	Participants will be prescribed 16 doses of 5mg tablets of oxycodone for postoperative pain relief.

Timeline

• Start date: 2024-07-12
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2024-08-01
• Last updated: 2024-08-02

Locations

1 site across 1 country: United States