Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery

Prospective Study of Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Opioid Use
• Intervention / Treatment: Other: 5x Oxycodone Oral Tablets; Other: 16x Oxycodone Oral Tablets

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Recruiting
      • University of Tennessee Health Science Center
      • Contact: Amira Wohabrebbi, PhD; Phone Number: 901-545-7453; Email: awohabre@uthsc.edu
      • Contact: Annette Hickerson, RN; Phone Number: 901-448-4784; Email: abpayne@uthsc.edu
      • Principal Investigator: John O Schorge, MD
      • Sub-Investigator: Emma Ryan, BS
      • Sub-Investigator: Alex Samborski, MD
      • Sub-Investigator: Caroline Reidy, BS
      • Sub-Investigator: Rachel Nelson, MD
      • Sub-Investigator: Daniel Amram, BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 Doses; Participants will receive 5 doses of prescription opioids following surgery.	Other: 5x Oxycodone Oral Tablets; Participants will be prescribed 5 doses of 5mg tablets of oxycodone for postoperative pain relief.
Active Comparator: 16 Doses; Participants will receive 16 doses of prescription opioids following surgery.	Other: 16x Oxycodone Oral Tablets; Participants will be prescribed 16 doses of 5mg tablets of oxycodone for postoperative pain relief.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pills used	All participants will be contacted on postoperative days 2 and 7 to inquire how many pills they have taken	Within 1 week following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	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.	Within 2 weeks following surgery

Collaborators and Investigators

• Sponsor: University of Tennessee

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: 24-09978-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes