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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03448315
Recruitment Status : Active, not recruiting
First Posted : February 28, 2018
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Shereen Mamdouh, Assiut University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : December 2, 2017
Actual Primary Completion Date : April 1, 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. total morphine comsuption [ Time Frame: 48 hours ]
    the total dose of morphine used as analgesic expressed in mg


Secondary Outcome Measures :
  1. Visual analogue scale [ Time Frame: 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)

  2. Douleur Neuropathique 4 questions DN4 [ Time Frame: 1month, 3month, 6 month ]
    the possibility of development of neuropathic pain will be assessed using DN4 scale


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448315


Locations
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Egypt
South Egypt Cancer Institute
Assiut, Egypt, 11715
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Shereen Mamdouh, Lectruer of anesthesia, ICU and pain manegement, Assiut University
ClinicalTrials.gov Identifier: NCT03448315    
Other Study ID Numbers: 405
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shereen Mamdouh, Assiut University:
brain stimulation, tDCS, acute postoperative pain, chronic pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations