From ACute To Chronic Postoperative Pain in Patients for Elective Cholecystectomy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01553253

Acronym

FACTS1

Enrollment

100

Registered

2012-03-14

Start date

2010-04-30

Completion date

2012-06-30

Last updated

2014-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Postcholecystectomy Pain, Chronic Postoperative Pain, Visceral Pain, Referred pain, Somatic pain, Quantitative Sensory Testing

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Abdominal pain	12 months

Secondary

Measure	Time frame	Description
Quantitative sensory testing values in referred pain area.	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
Abdominal pain	6 months	—

Countries

Denmark

Outcome results