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Clinical Trials/NCT00739544
NCT00739544
Unknown
Early Phase 1

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

Rigshospitalet, Denmark1 site in 1 country20 target enrollmentAugust 2008
ConditionsPain Threshold

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Pain Threshold
Sponsor
Rigshospitalet, Denmark
Enrollment
20
Locations
1
Primary Endpoint
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
Last Updated
17 years ago

Overview

Brief Summary

The purpose of this study is to identify intraindividual as well as iatrogenic factors disposing for the development of chronic and acute pains after surgery for breast cancer in order to improve treatment and prevent the development of acute and chronic postoperative pains.

Detailed Description

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 therapy.

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
March 2010
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Healthy women

Exclusion Criteria

  • Pregnancy
  • Lactating

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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