Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-12

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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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

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Opioid Use Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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5 Doses

Participants will receive 5 doses of prescription opioids following surgery.

Group Type EXPERIMENTAL

5x Oxycodone Oral Tablets

Intervention Type OTHER

Participants will be prescribed 5 doses of 5mg tablets of oxycodone for postoperative pain relief.

16 Doses

Participants will receive 16 doses of prescription opioids following surgery.

Group Type ACTIVE_COMPARATOR

16x Oxycodone Oral Tablets

Intervention Type OTHER

Participants will be prescribed 16 doses of 5mg tablets of oxycodone for postoperative pain relief.

Interventions

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5x Oxycodone Oral Tablets

Participants will be prescribed 5 doses of 5mg tablets of oxycodone for postoperative pain relief.

Intervention Type OTHER

16x Oxycodone Oral Tablets

Participants will be prescribed 16 doses of 5mg tablets of oxycodone for postoperative pain relief.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes