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

This study has been completed.
Sponsor:
Collaborators:
Vejle Hospital
Oberstinde Kirsten Jensa la Cours Foundation
Information provided by (Responsible Party):
Morten Rune Eckhardt, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01546480
First received: March 2, 2012
Last updated: June 16, 2014
Last verified: June 2014

March 2, 2012
June 16, 2014
November 2011
February 2014   (final data collection date for primary outcome measure)
Spinal interleukine levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
12 months after surgery
Same as current
Complete list of historical versions of study NCT01546480 on ClinicalTrials.gov Archive Site
  • Blood interleukine levels [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • spinal enzyme levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    12 months after surgery
  • Blood enzyme levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    12 months after surgery
Same as current
Not Provided
Not Provided
 
From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood Serum Plasma Cerebrospinal fluid Saliva

Non-Probability Sample

Patients in group 1 and 2 previously participated in a study of postcholecystectomy pain.

Patients in group 3 are patients scheduled for elective surgery in spinal anesthesia at the participating centres.

Pain
Not Provided
  • Pain patients
    Patients with unexplained chronic abdominal pain 12 months after elective cholecystectomy
  • Operated painfree Patients
    Painfree patients 12 months after elective cholecystectomy
  • Nonoperated painfree patients
    Painfree patients with no previous abdominal operation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01546480
ImmT, 119
No
Morten Rune Eckhardt, Odense University Hospital
Odense University Hospital
  • Vejle Hospital
  • Oberstinde Kirsten Jensa la Cours Foundation
Not Provided
Odense University Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP