From ACute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy

NCT ID: NCT01553253

Last Updated: 2014-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Region of Southern Denmark

OTHER

Sponsor Role collaborator

Vejle Hospital

OTHER

Sponsor Role collaborator

Manufacturer Mads Clausen Foundation

OTHER

Sponsor Role collaborator

DASAIMS Forskningsinitiativ

UNKNOWN

Sponsor Role collaborator

Fonden Else Poulsens Mindelegat

UNKNOWN

Sponsor Role collaborator

Oberstinde Kirsten Jensa la Cours Foundation

OTHER

Sponsor Role collaborator

Læge Frk. K. Rasmussens Mindelegat

UNKNOWN

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Morten Rune Eckhardt

Afdelingslæge, Ph.D.-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Odense University Hospital

Nyborg, , Denmark

Site Status

Lillebælt Hospital

Vejle, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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FACTS1

Identifier Type: -

Identifier Source: org_study_id

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