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Study to Test the Value of a Pain Modulation Test in Predicting Persistent Postoperative Pain After Breast Cancer Surgery (PREDO)

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Benno Rehberg-Klug, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01767168
First received: January 10, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

The purpose of this study is to test the hypothesis that a preoperative test of pain modulation predicts persistent pain 4 months after breast cancer surgery.


Condition
Chronic Pain
Acute Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trial of Diagnostic Accuracy for the Prediction of Persistent Postoperative Pain After Breast Cancer Surgery Using a Conditioned Pain Modulation Test

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • prevalence of pain at the site of surgery [ Time Frame: 4 months postop ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

venous blood sample


Estimated Enrollment: 180
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

women scheduled for any type of breast cancer surgery in a university hospital breast cancer center

Criteria

Inclusion Criteria:

  • age >=18 years
  • American Society of Anesthesiology functional status I-III
  • able to read and understand the information sheet and give informed consent

Exclusion Criteria:

none

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767168

Contacts
Contact: Benno Rehberg-Klug, MD +41 22 3823476 benno.rehberg-klug@hucge.ch
Contact: Stanislas Mathivon, ISA +41 22 37 27403 stanislas.mathivon@hcuge.ch

Locations
Switzerland
Hôpitaux Universitaires de Genève Recruiting
Geneva, Switzerland, 1211
Contact: Benno Rehberg-Klug, MD         benno.rehberg-klug@hcuge.ch    
Principal Investigator: Benno Rehberg-Klug, MD            
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Benno Rehberg-Klug, MD Dept of Anesthesiology, HUG
  More Information

No publications provided

Responsible Party: Benno Rehberg-Klug, médecin adjoint agrégé, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01767168     History of Changes
Other Study ID Numbers: CER 10-218, matped 10-054
Study First Received: January 10, 2013
Last Updated: January 10, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Breast Neoplasms
Pain, Postoperative
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013