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

This study has been completed.
Sponsor:
Collaborators:
University of Southern Denmark
Region Southern Denmark
Vejle Hospital
Fabrikant Mads Clausens Fond
DASAIMS Forskningsinitiativ
Fonden Else Poulsens Mindelegat
Oberstinde Kirsten Jensa la Cours Foundation
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: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: From Acute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy: The Significance of Components of Pain

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Abdominal pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 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 [ 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 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



Biospecimen Retention:   Samples With DNA

Whole Blood


Enrollment: 100
Study Start Date: April 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive Patients for elective cholecystectomy

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01553253

Locations
Denmark
Odense University Hospital
Nyborg, Denmark, 5800
Lillebælt Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Region Southern Denmark
Vejle Hospital
Fabrikant Mads Clausens Fond
DASAIMS Forskningsinitiativ
Fonden Else Poulsens Mindelegat
Oberstinde Kirsten Jensa la Cours Foundation
Læge Frk. K. Rasmussens Mindelegat
  More Information

No publications provided

Responsible Party: Morten Rune Eckhardt, Afdelingslæge, Ph.D.-student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01553253     History of Changes
Other Study ID Numbers: FACTS1
Study First Received: March 2, 2012
Last Updated: June 16, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
Postcholecystectomy Pain
Chronic Postoperative Pain
Visceral Pain
Referred pain
Somatic pain
Quantitative Sensory Testing

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014