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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 has been completed.
Information provided by (Responsible Party):
Benno Rehberg-Klug, University Hospital, Geneva Identifier:
First received: January 10, 2013
Last updated: July 29, 2016
Last verified: July 2016
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. In addition, a risk score for the prediction of persistent pain will be developed from parameters available before surgery.

Condition Intervention
Chronic Pain
Acute Pain
Other: comprehensive preoperative testing for risk factors of persistent postoperative 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 Benno Rehberg-Klug, University Hospital, Geneva:

Primary Outcome Measures:
  • prevalence of pain at the site of surgery [ Time Frame: 4 months postop ]
    clinically important pain defined as either necessitating analgesic treatment or having an intensity of more than 3/10 at rest or 5/10 on movement, at 4 months after surgery

Secondary Outcome Measures:
  • acute pain [ Time Frame: 24h ]
    maximum pain >3/10

  • subacute pain [ Time Frame: 1 week ]
    average pain, maximum pain >2

  • prevalence of pain necessitating analgesics at the site of surgery [ Time Frame: 4 months ]
  • prevalence of pain at the site of surgery [ Time Frame: 8 months ]
  • prevalence of pain at the site of surgery [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
venous blood sample

Enrollment: 200
Study Start Date: May 2011
Study Completion Date: May 2016
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: comprehensive preoperative testing for risk factors of persistent postoperative pain
    nociceptive reflex threshold, pain threshold, CPM-effect of hot water bath, pain sensitivity questionnaire, STAI, BDI, fear of surgical consequences

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

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:

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Please refer to this study by its identifier: NCT01767168

Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Principal Investigator: Benno Rehberg-Klug, MD Dept of Anesthesiology, HUG
  More Information

Responsible Party: Benno Rehberg-Klug, médecin adjoint agrégé, University Hospital, Geneva Identifier: NCT01767168     History of Changes
Other Study ID Numbers: CER 10-218
matped 10-054 ( Other Identifier: local ethics committee )
Study First Received: January 10, 2013
Last Updated: July 29, 2016

Additional relevant MeSH terms:
Pain, Postoperative
Chronic Pain
Acute Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms processed this record on May 25, 2017