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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03448315
Enrollment
30
Registered
2018-02-28
Start date
2017-12-02
Completion date
2021-12-31
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

brain stimulation, tDCS, acute postoperative pain, chronic pain

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.

Interventions

DEVICEtDCS

motor cortex stimulation (2 mA, 20 min for 4 sessions)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
total morphine comsuption48 hoursthe total dose of morphine used as analgesic expressed in mg

Secondary

MeasureTime frameDescription
Visual analogue scalebaseline,at 2,4,6, 12, 24,36,48 hourspatient asked to describe this pain with scores ranging from 0 to10 (with 0 = no pain and 10 = the worst pain imaginable)
Douleur Neuropathique 4 questions DN41month, 3month, 6 monththe possibility of development of neuropathic pain will be assessed using DN4 scale

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026