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NCT Number: NCT06532708

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee Health Science Center

Memphis, Tennessee, 38103, United States

Location status: Recruiting

Location contact

Alex Samborski, MD

SUB_INVESTIGATOR

Amira Wohabrebbi, PhD

CONTACT

[email protected]

901-545-7453

Annette Hickerson, RN

CONTACT

[email protected]

901-448-4784

Caroline Reidy, BS

SUB_INVESTIGATOR

Daniel Amram, BS

SUB_INVESTIGATOR

Emma Ryan, BS

SUB_INVESTIGATOR

John O Schorge, MD

PRINCIPAL_INVESTIGATOR

Rachel Nelson, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5x Oxycodone Oral Tablets

Other

Participants will be prescribed 5 doses of 5mg tablets of oxycodone for postoperative pain relief.

16x Oxycodone Oral Tablets

Other

Participants will be prescribed 16 doses of 5mg tablets of oxycodone for postoperative pain relief.

Primary outcomes

  1. Number of pills used

    Time frame: 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 outcomes

  1. Postoperative pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Official study title

Prospective Study of Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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