Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery
Prospective Study of Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2024
CompletedFirst Submitted
Initial submission to the registry
July 15, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedAugust 2, 2024
July 1, 2024
4 months
July 15, 2024
July 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Postoperative pain
Within 2 weeks following surgery
Study Arms (2)
5 Doses
EXPERIMENTALParticipants will receive 5 doses of prescription opioids following surgery.
16 Doses
ACTIVE COMPARATORParticipants will receive 16 doses of prescription opioids following surgery.
Interventions
Participants will be prescribed 5 doses of 5mg tablets of oxycodone for postoperative pain relief.
Participants will be prescribed 16 doses of 5mg tablets of oxycodone for postoperative pain relief.
Eligibility Criteria
You may qualify if:
- Women aged 18 to 80
- Undergoing planned laparoscopic hysterectomy as a day surgery procedure
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tennessee Health Science Center
Memphis, Tennessee, 38103, United States
Related Publications (2)
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.
PMID: 36716511BACKGROUNDWong 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.
PMID: 30837064BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2024
First Posted
August 1, 2024
Study Start
July 12, 2024
Primary Completion
October 31, 2024
Study Completion
October 31, 2024
Last Updated
August 2, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share