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OpenTrials
Completed

NCT Number: NCT01553253

From ACute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy

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.

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Key information

Conditions

Pain Neurologic Manifestations Nociceptive Pain Pain, Postoperative Pain, Referred Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Visceral Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital, Nyborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Abdominal pain

    Time frame: 12 months

Secondary outcomes

  1. 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

  2. Abdominal pain

    Time frame: 6 months

  3. 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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: FACTS1

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 14, 2012
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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