TEMporal PostOperative Pain Signatures

NCT ID: NCT02407743

Last Updated: 2021-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

428 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intervention Type BEHAVIORAL

Study the dynamic nature of pain

Genetic markers

Intervention Type GENETIC

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

Interventions

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Surgical patients' clinical progression

Study the dynamic nature of pain

Intervention Type BEHAVIORAL

Genetic markers

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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick J Tighe, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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UF Health

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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1R01GM114290-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR18877

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201500153 -N

Identifier Type: -

Identifier Source: org_study_id

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