Characterizing the Association Between Preoperative Depressive Symptoms and Opioid Use/Misuse After Surgery

NCT05412342 | Completed

• 1 other identifier: 43163
• Study Type: observational
• Target: 718
• Locations: 1 country
• Sites: 2

Brief Summary

This observational study aims to characterize the relationship between preoperative depressive symptoms and opioid use/ misuse after surgery using a perioperative learning health care system. We will follow a prospective cohort of patients undergoing elective surgery.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• Time to Opioid Cessation

  Assessed after surgery up to 1 year

Secondary Outcomes (1)

• Opioid Misuse

  Assessed after surgery up to 1 year

Study Arms (1)

Patients undergoing elective operations

We will follow a prospective cohort of 558 patients, undergoing any elective surgery at Stanford Hospital. Subjects will undergo baseline and longitudinal testing via a (including NIH Patient-Reported Outcomes Measurement Information System- PROMIS measures of emotional distress). After surgery, participants will report weekly changes in opioid use, pain, and adverse events; and monthly changes in opioid misuse for 1 year.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective surgery at Stanford Hospital.

You may qualify if:

• Age 18+
• Planning to undergo surgery
• English speaking
• Ability and willingness to complete questionnaires and assessments

You may not qualify if:

• Any conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
• Known Pregnancy
• Elevated Suicidality
• Enrollment in a conflicting perioperative trial

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

Stanford Health Care

Stanford, California, 94304, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: May 10, 2019
• Primary Completion: March 3, 2024
• Study Completion: March 3, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)