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

Sponsor

Assiut University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03448315

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Device: tDCS	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 2, 2017

Actual Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: real tDCS

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

Device: tDCS

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

Sham Comparator: sham tDCS

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

Device: tDCS

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

Outcome Measures

Primary Outcome Measures

total morphine comsuption [48 hours]
the total dose of morphine used as analgesic expressed in mg

Secondary Outcome Measures

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)
Douleur Neuropathique 4 questions DN4 [1month, 3month, 6 month]
the possibility of development of neuropathic pain will be assessed using DN4 scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Egypt Cancer Institute	Assiut		Egypt	11715

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shereen Mamdouh, Lectruer of anesthesia, ICU and pain manegement, Assiut University

ClinicalTrials.gov Identifier:

NCT03448315

Other Study ID Numbers:

First Posted:

Feb 28, 2018

Last Update Posted:

Oct 19, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shereen Mamdouh, Lectruer of anesthesia, ICU and pain manegement, Assiut University

brain stimulation, tDCS, acute postoperative pain, chronic pain

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Oct 19, 2020