TEMporal PostOperative Pain Signatures (TEMPOS)

Finding Good TEMporal PostOperative Pain Signatures (TEMPOS)

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Behavioral: Surgical patients' clinical progression; Genetic: Genetic markers

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 Type: Observational
• Enrollment (Actual): 428

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610-3003
      • UF Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for surgery will be invited to participate in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: Surgical patients' clinical progression; Study the dynamic nature of pain; Genetic: Genetic markers; Research variants in genes related to pain sensitivity, analgesic sensitivity and opioid response

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Patrick J Tighe, MD, Assistant Professor of Anesthesiology and Program Director, Perioperative Analytics Group Joint Assistant Professor of Orthopedics

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: analgesic; surgery; postoperative pain; pain intensity; persistent postsurgical pain; pain resolution; pain-related genes
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: IRB201500153 -N; 1R01GM114290-01 (U.S. NIH Grant/Contract); OCR18877 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO