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| Tracking Information | |||||||||
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| First Received Date † | August 20, 2008 | ||||||||
| Last Updated Date | August 20, 2008 | ||||||||
| Start Date † | August 2008 | ||||||||
| Current Primary Outcome Measures † |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Chronic Pain After Operation for Breast Cancer | ||||||||
| Official Title † | Examination of Healthy Female Subjects in the Project: Disposing Factors for Chronic Pain After Operation for Breast Cancer | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase 0 | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Single Blind (Subject), Single Group Assignment | ||||||||
| Condition † | Pain Threshold | ||||||||
| Intervention † | Other: 1 | ||||||||
| Study Arms / Comparison Groups | Other: Quantitative sensory testing (QST) of healthy women to create reference values for QST evaluation of women treated for breast cancer | ||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Enrolling by invitation | ||||||||
| Enrollment † | 20 | ||||||||
| Estimated Completion Date | March 2010 | ||||||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† | |||||||||
| Location Countries † | Denmark | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00739544 | ||||||||
| Responsible Party | Rune Gärtner MD, Department of Breast Cancer Surgery, RH, Copenhagen University, Denmark | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Rigshospitalet, Denmark | ||||||||
| Collaborators †† |
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| Investigators † |
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| Information Provided By | Rigshospitalet, Denmark | ||||||||
| Verification Date | August 2008 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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