From ACute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy

Completed

• Conditions: Pain

• Registration Number: NCT01553253
• Lead Sponsor: Odense University Hospital

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 available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-14
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-16
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients for elective cholecystectomy
• 18 years or older at the day of the operation
• Capable of speaking, reading and writing danish

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Exclusion Criteria

• Previous abdominal operation
• Patients with preoperative neuropathies
• Patients with other diseases in the nervous system, preoperative paresthesias or other sensory disturbances.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abdominal pain	12 months

Secondary Outcome Measures

Name	Time	Method
Quantitative sensory testing values in referred pain area.	6 Months	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
Abdominal pain	6 months

Trial Locations

Locations (2)

Odense University Hospital; 🇩🇰 Nyborg, Denmark

Lillebælt Hospital; 🇩🇰 Vejle, Denmark