Chronic Pain After Operation for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Pain Threshold

Keywords

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Reference Values Sensory Thresholds Pain Threshold Breast Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

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

Group Type OTHER

1

Intervention Type OTHER

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

Interventions

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1

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy women

Exclusion Criteria

* Pregnancy
* Lactating

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Department of Breast Cancer Surgery, RH, Copenhagen University, Denmark

Principal Investigators

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Niels Kroman, MD, DMSc

Role: STUDY_DIRECTOR

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

Henrik Kehlet, MD Ph.D DMSc

Role: STUDY_CHAIR

Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet (University of Copenhagen), Denmark

Locations

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

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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RH2101project.1.2008

Identifier Type: -

Identifier Source: org_study_id