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

June 16, 2014 updated by: Morten Rune Eckhardt, Odense University Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Nyborg, Denmark, 5800
        • Odense University Hospital
      • Vejle, Denmark, 7100
        • Lillebælt Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive Patients for elective cholecystectomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Abdominal pain
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative sensory testing values in referred pain area.
Time Frame: 12 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
12 Months
Abdominal pain
Time Frame: 6 months
6 months
Quantitative sensory testing values in referred pain area.
Time Frame: 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
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

University of Southern Denmark
Vejle Hospital
Region of Southern Denmark
Manufacturer Mads Clausen Foundation
Oberstinde Kirsten Jensa la Cours Foundation
DASAIMS Forskningsinitiativ
Fonden Else Poulsens Mindelegat
Læge Frk. K. Rasmussens Mindelegat

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 9, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

June 16, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FACTS1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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