Opioid Use, Postoperative Pain
Conditions
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.
Interventions
OTHER5x Oxycodone Oral Tablets
Participants will be prescribed 5 doses of 5mg tablets of oxycodone for postoperative pain relief.
OTHER16x Oxycodone Oral Tablets
Participants will be prescribed 16 doses of 5mg tablets of oxycodone for postoperative pain relief.
Sponsors
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed