Pain, PostoperativeTEMPOSNCT02407743
TEMporal PostOperative Pain Signatures
An observational study of Pain, Postoperative, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to determine what causes pain after surgery to increase or decrease over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Surgical patients' clinical progression and Genetic markers
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 428 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for surgery will be invited to participate in this study.
Who may be able to join
- 18 years of age or older
- anticipated length of hospital stay of 72 hours or greater
- expected post-operative survival greater than 6 months
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Surgical patients' clinical progression, Genetic markers
- Keywords
- postoperative pain, surgery, pain resolution, pain intensity, persistent postsurgical pain, pain-related genes, analgesic
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical patients' clinical progressionBehavioural
Study the dynamic nature of pain
Genetic markersGenetic
Research variants in genes related to pain sensitivity, analgesic sensitivity and opioid response
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Surgical patients' clinical progression; Genetic: Genetic markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure postoperative pain scores change with respect to time
Pain scores will be measured using previously established pain scale and Questionnaire
Measured: up to 7 days
Secondary outcomes (3)
Measure variables that contribute to postoperative pain scores
Variables: clinical, biological, psychological, and social factors
Measured: up to 6 months
Measure timing patterns that may influence development of persistent postsurgical pain (PPP)
Different patterns of pain analgesia-pain cycles
Measured: up to 6 months
Genetic testing
Specific single nucleotide polymorphisms
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Patrick J Tighe, MD, Principal investigator, Assistant Professor of Anesthesiology and Program Director, Perioperative Analytics Group Joint Assistant Professor of Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407743
- Sponsor's protocol ID
- IRB201500153 -N
- Other IDs
- 1R01GM114290-01, OCR18877
- Acronym
- TEMPOS
- Status last verified
- Jan 2021
- First submitted
- 9 Mar 2015
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding Good TEMporal PostOperative Pain Signatures (TEMPOS)
- ClinicalTrials.gov ID
- NCT02407743
- Acronym / sponsor ID
- TEMPOS / IRB201500153 -N
- Conditions
- Pain, Postoperative
- Keywords
- postoperative pain, surgery, pain resolution, pain intensity, persistent postsurgical pain, pain-related genes, analgesic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients' clinical progression | – | Behavioral: Surgical patients' clinical progression, Genetic: Genetic markersPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgery will be invited to participate in this study.
Key inclusion criteria (3 listed)
- 18 years of age or older
- anticipated length of hospital stay of 72 hours or greater
- expected post-operative survival greater than 6 months
Key exclusion criteria (4 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical patients' clinical progressionStudy the dynamic nature of pain | Behavioural | Surgical patients' clinical progression |
| Genetic markersResearch variants in genes related to pain sensitivity, analgesic sensitivity and opioid response | Genetic | Surgical patients' clinical progression |
Primary outcome
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
3 secondary outcomes
Measure variables that contribute to postoperative pain scores
Time frame: up to 6 months
Measure timing patterns that may influence development of persistent postsurgical pain (PPP)
Time frame: up to 6 months
Genetic testing
Time frame: up to 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J Tighe, MD principal investigator
Assistant Professor of Anesthesiology and Program Director, Perioperative Analytics Group Joint Assistant Professor of Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure postoperative pain scores change with respect to time (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.