PainFACTS1NCT01553253
From ACute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy
An observational study of Pain, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
Chronic Pain is a wellknown complication after cholecystectomy. Intensity of the pain in the first week after the operation is a predictive factor for the development of chronic pain, but it is unknown whether the risk is more related to one of the different components of acute pain (ie somatic, visceral, referred). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- Apr 2010to Jun 2012
- 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: Consecutive Patients for elective cholecystectomy
Who may be able to join
- Patients for elective cholecystectomy
- 18 years or older at the day of the operation
- Capable of speaking, reading and writing danish
Who cannot join
- Previous abdominal operation
- Patients with preoperative neuropathies
- Patients with other diseases in the nervous system, preoperative paresthesias or other sensory disturbances.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Odense University Hospital
Nyborg, 5800
Lillebælt Hospital
Vejle, 7100
About this study
Official title: From Acute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy: The Significance of Components of Pain
Chronic Pain is a wellknown complication after cholecystectomy. Intensity of the pain in the first week after the operation is a predictive factor for the development of chronic pain, but it is unknown whether the risk is more related to one of the different components of acute pain (ie somatic, visceral, referred). Furthermore the chronic pain has not been systematically described in terms of type of pain or sensory abnormalities etc. (allodynia, hyperalgesia etc.).
The purpose of the study is to examine whether intensity of components of acute pain is predictive for development of chronic pain after cholecystectomy and to characterize the chronic pain by quantitative sensory testing.
DNA-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.
- Conditions
- Pain
- Keywords
- Postcholecystectomy Pain, Chronic Postoperative Pain, Visceral Pain, Referred pain, Somatic pain, Quantitative Sensory Testing
- Medical subject headings
- Pain, Pain, Postoperative, Visceral Pain, Pain, Referred, Nociceptive Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain
Measured: 12 months
Secondary outcomes (3)
Quantitative sensory testing values in referred pain area.
Quantitative sensory testing values in referred pain area compared to contralateral side and preoperative values.
The following quantitative sensory tests are performed:
Cold Detection Threshold,Warm Detection Threshold, Cold Pain Threshold, Heat Pain Threshold, Mechanical detection Threshold, Mechanical Pain Threshold, Allodynia, Hyperalgesia, Wind-Up Ratio, Vibration Detection Threshold, Pressure Pain Threshold
Measured: 12 Months
Abdominal pain
Measured: 6 months
Quantitative sensory testing values in referred pain area.
Quantitative sensory testing values in referred pain area compared to contralateral side and preoperative values.
The following quantitative sensory tests are performed:
Cold Detection Threshold,Warm Detection Threshold, Cold Pain Threshold, Heat Pain Threshold, Mechanical detection Threshold, Mechanical Pain Threshold, Allodynia, Hyperalgesia, Wind-Up Ratio, Vibration Detection Threshold, Pressure Pain Threshold
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startApr 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Region of Southern Denmark, Vejle Hospital, Manufacturer Mads Clausen Foundation, DASAIMS Forskningsinitiativ, Fonden Else Poulsens Mindelegat, Oberstinde Kirsten Jensa la Cours Foundation, Læge Frk. K. Rasmussens Mindelegat
- Responsible party
- Principal investigator, Morten Rune Eckhardt, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553253
- Sponsor's protocol ID
- FACTS1
- Acronym
- FACTS1
- Status last verified
- Jun 2014
- First submitted
- 2 Mar 2012
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Acute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy: The Significance of Components of Pain
- ClinicalTrials.gov ID
- NCT01553253
- Acronym / sponsor ID
- FACTS1 / FACTS1
- Conditions
- Pain
- Keywords
- Postcholecystectomy Pain, Chronic Postoperative Pain, Visceral Pain, Referred pain, Somatic pain, Quantitative Sensory Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Region of Southern Denmark, Vejle Hospital, Manufacturer Mads Clausen Foundation, DASAIMS Forskningsinitiativ, Fonden Else Poulsens Mindelegat, Oberstinde Kirsten Jensa la Cours Foundation, Læge Frk. K. Rasmussens Mindelegat
- Study start
- Apr 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Mar 2012 (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.
Chronic Pain is a wellknown complication after cholecystectomy. Intensity of the pain in the first week after the operation is a predictive factor for the development of chronic pain, but it is unknown whether the risk is more related to one of the different components of acute pain (ie somatic, visceral, referred). Furthermore the chronic pain has not been systematically described in terms of type of pain or sensory abnormalities etc. (allodynia, hyperalgesia etc.).
The purpose of the study is to examine whether intensity of components of acute pain is predictive for development of chronic pain after cholecystectomy and to characterize the chronic pain by quantitative sensory testing.
DNA-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive Patients for elective cholecystectomy
Key inclusion criteria (3 listed)
- Patients for elective cholecystectomy
- 18 years or older at the day of the operation
- Capable of speaking, reading and writing danish
Key exclusion criteria (3 listed)
- Previous abdominal operation
- Patients with preoperative neuropathies
- Patients with other diseases in the nervous system, preoperative paresthesias or other sensory disturbances.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Abdominal pain
Time frame: 12 months
3 secondary outcomes
Quantitative sensory testing values in referred pain area.
Time frame: 12 Months
Abdominal pain
Time frame: 6 months
Quantitative sensory testing values in referred pain area.
Time frame: 6 Months
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 17 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Odense University Hospital at 2 sites in Denmark.
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 3 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 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Abdominal pain (time frame: 12 months). 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 17 Jun 2014.