TEMporal PostOperative Pain Signatures

NCT02407743 | Completed

• 3 other identifiers: IRB201500153 -N1R01GM114290-01OCR18877
• Study Type: observational
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative

Keywords

postoperative pain; surgery; pain resolution; pain intensity; persistent postsurgical pain; pain-related genes; analgesic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Measure variables that contribute to postoperative pain scores

  up to 6 months

• Measure timing patterns that may influence development of persistent postsurgical pain (PPP)

  up to 6 months

• Genetic testing

  up to 1 day

Study Arms (1)

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; Genetic: Genetic markers

Interventions

Surgical patients' clinical progression BEHAVIORAL

Study the dynamic nature of pain

Surgical patients' clinical progression

Genetic markers GENETIC

Research variants in genes related to pain sensitivity, analgesic sensitivity and opioid response

Surgical patients' clinical progression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

UF Health

Gainesville, Florida, 32610-3003, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Genetic Markers

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biomarkers; Biological Factors; Phenotype; Genetic Phenomena

Study Officials

• Patrick J Tighe, MD

  Assistant Professor of Anesthesiology and Program Director, Perioperative Analytics Group Joint Assistant Professor of Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: April 3, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)