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

June 16, 2014 updated by: Morten Rune Eckhardt, Odense University Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital
      • Vejle, Denmark, 7100
        • Lillebælt Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal interleukine levels
Time Frame: 12 months
12 months after surgery
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood interleukine levels
Time Frame: 12 Months
12 Months
spinal enzyme levels
Time Frame: 12 months
12 months after surgery
12 months
Blood enzyme levels
Time Frame: 12 months
12 months after surgery
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

Vejle Hospital
Oberstinde Kirsten Jensa la Cours Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

June 16, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ImmT
  • 119 (hhh)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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