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

This study is currently recruiting participants.
Verified March 2012 by Odense University Hospital
Sponsor:
Collaborators:
Vejle Hospital
Oberstinde Kirsten Jensa la Cours Legat
Information provided by (Responsible Party):
Morten Rune Eckhardt, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01546480
First received: March 2, 2012
Last updated: March 9, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Spinal interleukine levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    12 months after surgery


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

Whole blood Serum Plasma Cerebrospinal fluid Saliva


Estimated Enrollment: 45
Study Start Date: November 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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

Exclusion Criteria:

  • Acute or chronic pain condition
  • Immunosuppressive treatment (NSAID excepted)
  • Previous abdominal operation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546480

Contacts
Contact: Morten R Eckhardt, MD +45 6541 2528 morten.rune.eckhardt@ouh.regionsyddanmark.dk
Contact: Palle Toft, MD PHD DrMed +45 6541 3947 palle.toft@ouh.regionsyddanmark.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Morten R Eckhardt, MD     +45 6541 2528     morten.rune.eckhardt@ouh.regionsyddanmark.dk    
Contact: Palle Toft, MD PHD DrMed     +45 6541 3947     palle.toft@ouh.regionsyddanmark.dk    
Principal Investigator: Morten R Eckhardt, MD            
Lillebælt Hospital Recruiting
Vejle, Denmark, 7100
Contact: Morten R Eckhardt, MD     +45 6541 2528     morten.rune.eckhardt@ouh.regionsyddanmark.dk    
Contact: Helle Ørding, MD DrMed     +45 7940 6205     Helle.Oerding@slb.regionsyddanmark.dk    
Principal Investigator: Morten R Eckhardt, MD            
Sponsors and Collaborators
Odense University Hospital
Vejle Hospital
Oberstinde Kirsten Jensa la Cours Legat
  More Information

No publications provided

Responsible Party: Morten Rune Eckhardt, Afdelingslæge, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01546480     History of Changes
Other Study ID Numbers: ImmT, 119
Study First Received: March 2, 2012
Last Updated: March 9, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Chronic postoperative pain
Postcholecystectomy pain
Inflammation
Interleukines

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

ClinicalTrials.gov processed this record on May 23, 2013