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
  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


Enrollment: 18
Study Start Date: November 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546480

Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Lillebælt Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Odense University Hospital
Vejle Hospital
Oberstinde Kirsten Jensa la Cours Foundation
  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: June 16, 2014
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 July 23, 2014