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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Benno Rehberg-Klug, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01767168
First received: January 10, 2013
Last updated: August 26, 2015
Last verified: August 2015

January 10, 2013
August 26, 2015
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01767168 on ClinicalTrials.gov Archive Site
  • acute pain [ Time Frame: 24h ] [ Designated as safety issue: No ]
    maximum pain >3/10
  • subacute pain [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    average pain, maximum pain >2
  • prevalence of pain necessitating analgesics at the site of surgery [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • prevalence of pain at the site of surgery [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • prevalence of pain at the site of surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.

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.
 
Active, not recruiting
180
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:

none

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01767168
CER 10-218, matped 10-054
No
Benno Rehberg-Klug, University Hospital, Geneva
University Hospital, Geneva
Not Provided
Principal Investigator: Benno Rehberg-Klug, MD Dept of Anesthesiology, HUG
University Hospital, Geneva
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP