Clinical trial NCT06532708: Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery
Official title: Prospective Study of Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use
Postoperative Pain
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of pills used
timeFrame: Within 1 week following surgery
Secondary outcomes:
measure: Postoperative pain
timeFrame: Within 2 weeks following surgery
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
References:
citation: Straubhar AM, Stroup C, de Bear O, Dalton L, Rolston A, McCool K, Reynolds RK, McLean K, Siedel JH, Uppal S. Provider compliance with a tailored opioid prescribing calculator in gynecologic surgery. Gynecol Oncol. 2023 Mar;170:229-233. doi: 10.1016/j.ygyno.2023.01.018. Epub 2023 Jan 28.
citation: Wong M, Vogell A, Wright K, Isaacson K, Loring M, Morris S. Opioid use after laparoscopic hysterectomy: prescriptions, patient use, and a predictive calculator. Am J Obstet Gynecol. 2019 Mar;220(3):259.e1-259.e11. doi: 10.1016/j.ajog.2018.10.022. Epub 2018 Oct 25.