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. (see Contacts and Locations)
Verified August 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: August 14, 2013
Last verified: August 2013
  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:


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
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: 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: August 14, 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 July 24, 2014