Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery

University of Tennessee

Status: Enrolling

Conditions: Postoperative Pain; Opioid Use

Treatments: Other: 5x Oxycodone Oral Tablets; Other: 16x Oxycodone Oral Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT06532708

24-09978-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

5 Doses

Experimental group

Description:

Participants will receive 5 doses of prescription opioids following surgery.

Treatment:

Other: 5x Oxycodone Oral Tablets

16 Doses

Active Comparator group

Description:

Participants will receive 16 doses of prescription opioids following surgery.

Treatment:

Other: 16x Oxycodone Oral Tablets