From ACute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy

Pain Clinical Trial

— FACTS1  

Official title:

From Acute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy: The Significance of Components of Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553253
• Other study ID #: FACTS1
• Status: Completed
• Phase: N/A
• First received: March 2, 2012
• Last updated: June 16, 2014
• Start date: April 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Nyborg
Denmark	Lillebælt Hospital	Vejle

Sponsors (9)

Lead Sponsor	Collaborator
Odense University Hospital	DASAIMS Forskningsinitiativ, Fabrikant Mads Clausens Fond, Fonden Else Poulsens Mindelegat, Læge Frk. K. Rasmussens Mindelegat, Oberstinde Kirsten Jensa la Cours Foundation, Region of Southern Denmark, University of Southern Denmark, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal pain		12 months	No
Secondary	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	12 Months	No
Secondary	Abdominal pain		6 months	No
Secondary	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	6 Months	No