Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery

Not Applicable

Recruiting

• Conditions: Postoperative Pain; Opioid Use
• Interventions: Other: 5x Oxycodone Oral Tablets; Other: 16x Oxycodone Oral Tablets

• Registration Number: NCT06532708
• Lead Sponsor: University of Tennessee

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.

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-12
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-31
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 Doses	5x Oxycodone Oral Tablets	Participants will receive 5 doses of prescription opioids following surgery.
16 Doses	16x Oxycodone Oral Tablets	Participants will receive 16 doses of prescription opioids following surgery.

Primary Outcome Measures

Name	Time	Method
Number of pills used	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 Outcome Measures

Name	Time	Method
Postoperative pain	Within 2 weeks following surgery	All participants will be contacted on postoperative days 2 and 7, and at their two-week follow-up visit to inquire where their pain level is on the Visual Analog Scale (VAS). This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst possible pain.

Trial Locations

Locations (1)

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States