TEMporal PostOperative Pain Signatures

Completed

• Conditions: Pain, Postoperative
• Interventions: Behavioral: Surgical patients' clinical progression; Genetic: Genetic markers

• Registration Number: NCT02407743
• Lead Sponsor: University of Florida

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-04-03
• Study Start: 2015-08
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 428

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical patients' clinical progression	Surgical patients' clinical progression	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.
Surgical patients' clinical progression	Genetic markers	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.

Primary Outcome Measures

Name	Time	Method
Measure postoperative pain scores change with respect to time	up to 7 days	Pain scores will be measured using previously established pain scale and Questionnaire

Secondary Outcome Measures

Name	Time	Method
Measure timing patterns that may influence development of persistent postsurgical pain (PPP)	up to 6 months	Different patterns of pain analgesia-pain cycles
Genetic testing	up to 1 day	Specific single nucleotide polymorphisms
Measure variables that contribute to postoperative pain scores	up to 6 months	Variables: clinical, biological, psychological, and social factors

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States