From ACute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy (FACTS1)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

University of Southern Denmark

Vejle Hospital

Fabrikant Mads Clausens Fond

DASAIMS Forskningsinitiativ

Fonden Else Poulsens Mindelegat

Oberstinde Kirsten Jensa la Cours Legat

Læge Frk. K. Rasmussens Mindelegat

Information provided by (Responsible Party):

Morten Rune Eckhardt, Odense University Hospital

ClinicalTrials.gov Identifier:

NCT01553253

First received: March 2, 2012

Last updated: March 14, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 2, 2012
Last Updated Date	March 14, 2012
Start Date ^ICMJE	April 2010
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 9, 2012)	Abdominal pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01553253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 9, 2012)	Quantitative sensory testing values in referred pain area. [ Time Frame: 12 Months ] [ Designated as safety issue: No ] Quantitative sensory testing values in referred pain area compared to kontralateral side and preoperative values. The following quantitative sensory tests are performed: Cold Detection Threshold,Warm Detection Threshold, Cold Pain Threshold, Heat Pain Threshhold, Mechanical detection Threshhold, Mechanical Pain Threshold, Allodynia, Hyperalgesia, Wind-Up Ratio, Vibration Detection Threshold, Pressure Pain Threshold Abdominal pain [ Time Frame: 6 months ] [ Designated as safety issue: No ] Quantitative sensory testing values in referred pain area. [ Time Frame: 6 Months ] [ Designated as safety issue: No ] Quantitative sensory testing values in referred pain area compared to kontralateral side and preoperative values. The following quantitative sensory tests are performed: Cold Detection Threshold,Warm Detection Threshold, Cold Pain Threshold, Heat Pain Threshhold, Mechanical detection Threshhold, Mechanical Pain Threshold, Allodynia, Hyperalgesia, Wind-Up Ratio, Vibration Detection Threshold, Pressure Pain Threshold
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	From ACute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy
Official Title ^ICMJE	From Acute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy: The Significance of Components of Pain
Brief 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). 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Whole Blood
Sampling Method	Non-Probability Sample
Study Population	Consecutive Patients for elective cholecystectomy
Condition ^ICMJE	Pain
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	June 2012
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients for elective cholecystectomy 18 years or older at the day of the operation Capable of speaking, reading and writing danish Exclusion Criteria: Previous abdominal operation Patients with preoperative neuropathies Patients with other diseases in the nervous system, preoperative paresthesias or other sensory disturbances.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01553253
Other Study ID Numbers ^ICMJE	FACTS1
Has Data Monitoring Committee	No
Responsible Party	Morten Rune Eckhardt, Odense University Hospital
Study Sponsor ^ICMJE	Odense University Hospital
Collaborators ^ICMJE	University of Southern Denmark Vejle Hospital Fabrikant Mads Clausens Fond DASAIMS Forskningsinitiativ Fonden Else Poulsens Mindelegat Oberstinde Kirsten Jensa la Cours Legat Læge Frk. K. Rasmussens Mindelegat
Investigators ^ICMJE	Not Provided
Information Provided By	Odense University Hospital
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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