Recruiting

Observational Study

Sponsor:

University of Tennessee

Code:

NCT06532708

Conditions

Opioid Use

Postoperative Pain

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

5x Oxycodone Oral Tablets

16x Oxycodone Oral Tablets

Study Details

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.

Conditions

Opioid Use

Postoperative Pain

Study ID

NCT06532708

Start date

Jul 12, 2024

Status verified date

Jul, 2024

Completion date

Oct 31, 2024

Anticipated

Primary completion date

Oct 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 5 Doses

Participants will receive 5 doses of prescription opioids following surgery.

active comparator: 16 Doses

Participants will receive 16 doses of prescription opioids following surgery.

Interventions

5x Oxycodone Oral Tablets

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

16x Oxycodone Oral Tablets

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

Primary outcome measure

  • Number of pills used [ Time Frame: Within 1 week following surgery ]

Central Contacts and Locations

Locations

University of Tennessee Health Science Center

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Amira Wohabrebbi, PhD

901-545-7453awohabre@uthsc.edu

Annette Hickerson, RN

901-448-4784abpayne@uthsc.edu

Principal Investigator:

John O Schorge, MD

More Information

Sponsor

University of Tennessee

Last update posted

Aug 2, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2024-08-02.