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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03448315
• Other study ID #: 405
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2, 2017
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• tDCS
motor cortex stimulation (2 mA, 20 min for 4 sessions)

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total morphine comsuption	the total dose of morphine used as analgesic expressed in mg	48 hours
Secondary	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
Secondary	Douleur Neuropathique 4 questions DN4	the possibility of development of neuropathic pain will be assessed using DN4 scale	1month, 3month, 6 month