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Completed

NCT Number: NCT02407743

TEMporal PostOperative Pain Signatures

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health

Gainesville, Florida, 32610-3003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical patients' clinical progression

Behavioral

Study the dynamic nature of pain

Genetic markers

Genetic

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Measure variables that contribute to postoperative pain scores

    Time frame: up to 6 months

    Variables: clinical, biological, psychological, and social factors

  2. 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

  3. Genetic testing

    Time frame: up to 1 day

    Specific single nucleotide polymorphisms

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Finding Good TEMporal PostOperative Pain Signatures (TEMPOS)

Acronym: TEMPOS

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2015
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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