From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests

Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to persisting inflammation.

The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod at patients 12 months after the operation.

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 Inflammation Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital, Odense, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Group 1:

Inclusion criteria

Unexplained abdominal pain 12 months after elective cholecystectomy

Exclusion criteria

Immunosuppressive treatment (NSAID excepted)
Anticoagulant treatment

Group 2:

Inclusion criteria

No pain 12 months after elective cholecystectomy

Exclusion criteria

Immunosuppressive treatment (NSAID excepted)
Anticoagulant treatment

Group 3:

Inclusion criteria

Elective operation in spinal anesthesia or
Or healthy volunteers accepting samples of blod, cerebral spinal fluid and saliva, to be collected

Exclusion criteria

Acute or chronic pain condition
Immunosuppressive treatment (NSAID excepted)
Previous abdominal operation

Treatment and study plan

Primary outcomes

Spinal interleukine levels

Time frame: 12 months

12 months after surgery

Secondary outcomes

Blood interleukine levels

Time frame: 12 Months
spinal enzyme levels

Time frame: 12 months

12 months after surgery
Blood enzyme levels

Time frame: 12 months

12 months after surgery

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

Oberstinde Kirsten Jensa la Cours Foundation
Vejle Hospital

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Mar 7, 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.

View the official ClinicalTrials.gov record (opens in a new tab)

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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