Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT04974463

Conditions

Joint Pain

Chronic Pain

Opioid Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Personalized medicine is a concept in which medical care is individualized to a patient based on their unique characteristics, including comorbidities, demographics, genetics, and microbiome. After major surgery, some patients are at increased risk of opioid dependence. By identifying unique genetic and microbiome markers, clinicians may potentially identify individual risk factors for opioid dependence. By identifying these high risk patients early-on, personalized interventions may be applied to these patients in order to reduce the incidence of opioid-dependence.

Conditions

Joint Pain

Chronic Pain

Opioid Use

Study ID

NCT04974463

Start date

Jul 19, 2021

Status verified date

Jul, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Oct 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patient undergoing unilateral knee or hip arthroplasty

Exclusion Criteria:

  • refusal to consent
  • lack of independent decision-making capacity
  • inability to communicate effectively with research personnel
  • if patient received antibiotics within the last 3 months prior to surgery

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Persistent Opioid Use at 3 months

Patients who continue to use opioids about 3 months after their joint replacement surgery

No Persistent Opioid Use at 3 months

Patients who do not use opioids after about 3 months following joint replacement surgery

Primary outcome measure

  • 3-month persistent opioid use [ Time Frame: 3 months ]
  • 3-month persistent post-surgical pain [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Rodney A Gabriel, MD, MAS

858-663-7747ragabriel@health.ucsd.edu

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Rodney A Gabriel, MD

858-663-7747ragabriel@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Jul 27, 2023

Last verified

Jul, 2023

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 California, San Diego on 2023-07-27.