TEMporal PostOperative Pain Signatures (TEMPOS)

University of Florida

Status: Completed

Conditions: Pain, Postoperative

Treatments: Genetic: Genetic markers; Behavioral: Surgical patients' clinical progression

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02407743

1R01GM114290-01 (U.S. NIH Grant/Contract)

IRB201500153 -N

OCR18877 (Other Identifier)

Details and patient eligibility

About

The purpose of this research study is to determine what causes pain after surgery to increase or decrease over time.

Full description

Before surgery, study participants will be asked questions about age, gender, race/ethnicity, annual income, and education level. Study participants will also be questioned regarding prior pain experiences, their mood and how they think about pain. A small test tube of blood, a cheek swab or a saliva sample will be taken to see what genetic differences may influence individuals pain after surgery.

After surgery, study participants will be asked questions about their pain intensity while in the hospital. Additional information will be collected about the effects of pain medicine, and their recovery from surgery.

Following discharge from the hospital, study participants will be contacted monthly to confirm continued communication. Study participants will also be contacted six months after surgery, and asked to complete a final survey about their pain after surgery.

Enrollment: 428 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• anticipated length of hospital stay of 72 hours or greater
• expected post-operative survival greater than 6 months

Exclusion criteria

• < 18 years of age
• anticipated need for prolonged post-operative intubation (greater than 24 hours)
• urgent or emergent surgical procedure
• inability to understand or participate in questionnaires, surveys or data collection

Trial design

428 participants in 1 patient group

Surgical patients' clinical progression

Description:

Patients undergoing non-ambulatory surgery will be asked questions and complete surveys in an effort to characterize postoperative pain experience profiles. A blood sample will be obtained for genetic markers exploring a variety of pain-related genes.

Treatment:

Behavioral: Surgical patients' clinical progression

Genetic: Genetic markers