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

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ClinicalTrials.gov Identifier: NCT01767168
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
Benno Rehberg-Klug, University Hospital, Geneva

Brief Summary:
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 or disease Intervention/treatment
Chronic Pain Acute Pain Other: comprehensive preoperative testing for risk factors of persistent postoperative pain

Study Type : Observational
Actual Enrollment : 200 participants
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
Study Start Date : May 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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 :
  1. acute pain [ Time Frame: 24h ]
    maximum pain >3/10

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

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

Biospecimen Retention:   Samples With DNA
venous blood sample


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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767168


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

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 ( Other Identifier: local ethics committee )
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: August 1, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Pain, Postoperative
Chronic Pain
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms