Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery
Purpose
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.
Conditions
- Opioid Use
- Postoperative Pain
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 5 Doses |
Participants will receive 5 doses of prescription opioids following surgery. |
|
|
Active Comparator 16 Doses |
Participants will receive 16 doses of prescription opioids following surgery. |
|
Recruiting Locations
Memphis, Tennessee 38103
More Details
- Status
- Recruiting
- Sponsor
- University of Tennessee
Study Contact
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.