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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT00739544
Other study ID # RH2101project.1.2008
Secondary ID
Status Enrolling by invitation
Phase Phase 0
First received August 20, 2008
Last updated August 20, 2008
Start date August 2008
Est. completion date March 2010

Study information

Verified date August 2008
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 20
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Healthy women

Exclusion Criteria:

- Pregnancy

- Lactating

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
1
Testing with thermal sensor testing device, von Frey filaments, cotton wisp, turning fork, pressure gauge device

Locations

Country Name City State
Denmark Department of Breast Surgery, Centre of Head and Orthopaedics, Rigshospitalet (university of Copenhagen) Copenhagen

Sponsors (3)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Danish Breast Cancer Cooperative Group, Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 From 08-20-2008 to 11-1-2008 test is performed two times with app one week in between No
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