Role of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management

Study Overview
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Brief Summary
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the role of transcranial magnetic stimulation over the primary motor cortex area on acute postoperative pain after breast cancer surgery and on the probability of developing chronic neuropathic pain.

Detailed Description
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New analgesic strategies are needed that can be used adjunctively to existing strategies with the potential to reduce reliance on opioid analgesia. Several novel brain stimulation technologies including transcranial direct current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety of pain conditions. Electricity has no metabolite or other residue, and can be delivered with minimal discomfort and without problems associated with drug-drug interactions.Transcranial direct current stimulation has been studied in patients with various disorders and multiple pain syndromes. There is also evidence that tDCS might be useful in postsurgical pain reduction.

Official Title
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Role of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management

Conditions
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Postoperative Pain

Intervention / Treatment
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* Device: tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II, scheduled for unilateral modified radical mastectomy with axillary dissection for breast cancer Exclusion Criteria: patients with intracranial metallic devices or with pacemakers or any other device. patients with Neurological or psychiatric disorders, patients taking major centrally acting drugs (antiepileptics or antidepressants), -opioid dependence, substance abuse, severe cardiopulmonary, renal, hepatic diseases, and those with extensive myocardial ischemia or unstable angina.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: real tDCS<br>motor cortex stimulation (2 mA, 20 min for 4 sessions) | Device: tDCS<br>* motor cortex stimulation (2 mA, 20 min for 4 sessions)<br>|
| Sham Comparator: sham tDCS<br>motor cortex stimulation (2 mA, 20 min for 4 sessions) but stimulation device is turned off without the participant knowledge | Device: tDCS<br>* motor cortex stimulation (2 mA, 20 min for 4 sessions)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total morphine comsuption | the total dose of morphine used as analgesic expressed in mg | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | patient asked to describe this pain with scores ranging from 0 to10 (with 0 = no pain and 10 = the worst pain imaginable) | baseline,at 2,4,6, 12, 24,36,48 hours | 
| Douleur Neuropathique 4 questions DN4 | the possibility of development of neuropathic pain will be assessed using DN4 scale | 1month, 3month, 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain stimulation, tDCS, acute postoperative pain, chronic pain