TEMporal PostOperative Pain Signatures (TEMPOS)

January 15, 2021 updated by: University of Florida

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: up to 7 days
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
Time Frame: up to 6 months
Variables: clinical, biological, psychological, and social factors
up to 6 months
Measure timing patterns that may influence development of persistent postsurgical pain (PPP)
Time Frame: up to 6 months
Different patterns of pain analgesia-pain cycles
up to 6 months
Genetic testing
Time Frame: up to 1 day
Specific single nucleotide polymorphisms
up to 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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