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TEMporal PostOperative Pain Signatures

Finding Good TEMporal PostOperative Pain Signatures (TEMPOS)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02407743
Acronym
TEMPOS
Enrollment
428
Registered
2015-04-03
Start date
2015-08-31
Completion date
2020-08-31
Last updated
2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

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

Brief summary

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

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.

Interventions

BEHAVIORALSurgical patients' clinical progression

Study the dynamic nature of pain

GENETICGenetic markers

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

Sponsors

National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure postoperative pain scores change with respect to timeup to 7 daysPain scores will be measured using previously established pain scale and Questionnaire

Secondary

MeasureTime frameDescription
Measure variables that contribute to postoperative pain scoresup to 6 monthsVariables: clinical, biological, psychological, and social factors
Measure timing patterns that may influence development of persistent postsurgical pain (PPP)up to 6 monthsDifferent patterns of pain analgesia-pain cycles
Genetic testingup to 1 daySpecific single nucleotide polymorphisms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026