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

NCT ID: NCT03448315

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-02
• Study Completion Date: 2021-12-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

real tDCS

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

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: DEVICE

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

sham tDCS

motor cortex stimulation (2 mA, 20 min for 4 sessions) but stimulation device is turned off without the participant knowledge

Group Type: SHAM_COMPARATOR

tDCS

Intervention Type: DEVICE

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

Interventions

tDCS

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shereen Mamdouh

Lectruer of anesthesia, ICU and pain manegement

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

South Egypt Cancer Institute

Asyut, , Egypt

Countries

Egypt

Other Identifiers

405

Identifier Type: -

Identifier Source: org_study_id