Chronic Pain After Operation for Breast Cancer

Early Phase 1

• Conditions: Pain Threshold
• Interventions: Other: 1

• Registration Number: NCT00739544
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Status Verified: 2008-08
• Study Start: 2008-08
• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-20
• Last Update Submitted: 2008-08-20
• Study First Posted: 2008-08-21
• Last Update Posted: 2008-08-21
• Primary Completion: 2010-03
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Healthy women

Exclusion Criteria

• Pregnancy
• Lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	1	Quantitative sensory testing (QST) of healthy women to create reference values for QST evaluation of women treated for breast cancer

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Breast Surgery, Centre of Head and Orthopaedics, Rigshospitalet (university of Copenhagen); 🇩🇰 Copenhagen, Denmark