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Examination of Healthy Female Subjects in the Project: Disposing Factors for Chronic Pain After Operation for Breast Cancer

Phase 0
18 Years
70 Years
Open (Enrolling by invite only)
Pain Threshold

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Trial Information

Examination of Healthy Female Subjects in the Project: Disposing Factors for Chronic Pain After Operation for Breast Cancer

Surgery for breast cancer is followed by acute undesirable sequelae (pain, nausea, vomiting,
psycho-social adaptation) and late sequelae with discomfort or more severe neuropathic pain
problems in the surgical area due to nerve damage or adjuvant-/radiotherapy. The late
sequelae occur in 30-50% of patients but the exact mechanisms (preoperative disposing
factors, intraoperative nerve damage/inflammatory response), acute postoperative pain and
psychosocial factors remain to be determined in large, detailed, well-described studies,
including stratification to modern breast cancer treatment (sentinel node strategy/
radiotherapy/ chemotherapy). The present study will describe in detail preoperative
psychosocial/genetic pain mechanisms, intraoperative technique, multi-modal anaesthesia and
opioid-reduced analgesia with a detailed, early and late postoperative follow-up with
neurophysiological assessment in the surgical area and randomised studies on preventive

Inclusion Criteria:

- Healthy women

Exclusion Criteria:

- Pregnancy

- Lactating

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Reference values on: Cold and cold detection threshold,Paradoxical heat sensation,Thermal sensory limen procedure,Cold and heat pain threshold,Mechanical detection and pain threshold and sensitivity,Vibration detection threshold,Pressure pain threshold

Outcome Time Frame:

From 08-20-2008 to 11-1-2008 test is performed two times with app one week in between

Safety Issue:


Principal Investigator

Niels Kroman, MD, DMSc

Investigator Role:

Study Director

Investigator Affiliation:

Department of Breast Surgery, Centre of Head and Orthopaedics, Rigshospitalet (University of Copenhagen), Denmark


Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:




Start Date:

August 2008

Completion Date:

March 2010

Related Keywords:

  • Pain Threshold
  • Reference Values
  • Sensory Thresholds
  • Pain Threshold
  • Breast Neoplasms
  • Breast Neoplasms