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

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Device: tDCS

• Registration Number: NCT03448315
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-12-02
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-28
• Primary Completion: 2019-04-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• ASA I-II, scheduled for unilateral modified radical mastectomy with axillary dissection for breast cancer

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham tDCS	tDCS	motor cortex stimulation (2 mA, 20 min for 4 sessions) but stimulation device is turned off without the participant knowledge
real tDCS	tDCS	motor cortex stimulation (2 mA, 20 min for 4 sessions)

Primary Outcome Measures

Name	Time	Method
total morphine comsuption	48 hours	the total dose of morphine used as analgesic expressed in mg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

South Egypt Cancer Institute; 🇪🇬 Assiut, Egypt