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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767168
First Posted: January 14, 2013
Last Update Posted: August 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Benno Rehberg-Klug, University Hospital, Geneva
January 10, 2013
January 14, 2013
August 1, 2016
May 2011
April 2015   (Final data collection date for primary outcome measure)
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
prevalence of pain at the site of surgery [ Time Frame: 4 months postop ]
Complete list of historical versions of study NCT01767168 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Study to Test the Value of a Pain Modulation Test in Predicting Persistent Postoperative Pain After Breast Cancer Surgery
Trial of Diagnostic Accuracy for the Prediction of Persistent Postoperative Pain After Breast Cancer Surgery Using a Conditioned Pain Modulation Test
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
venous blood sample
Non-Probability Sample
women scheduled for any type of breast cancer surgery in a university hospital breast cancer center
  • Chronic Pain
  • Acute Pain
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
May 2016
April 2015   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01767168
CER 10-218
matped 10-054 ( Other Identifier: local ethics committee )
No
Not Provided
Not Provided
Benno Rehberg-Klug, University Hospital, Geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Benno Rehberg-Klug, MD Dept of Anesthesiology, HUG
University Hospital, Geneva
July 2016