Back to resultsRole of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring brain stimulation, tDCS, acute postoperative pain, chronic pain
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.
Sites / Locations
- South Egypt Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
real tDCS
sham tDCS
Arm Description
motor cortex stimulation (2 mA, 20 min for 4 sessions)
motor cortex stimulation (2 mA, 20 min for 4 sessions) but stimulation device is turned off without the participant knowledge
Outcomes
Primary Outcome Measures
total morphine comsuption
the total dose of morphine used as analgesic expressed in mg
Secondary Outcome Measures
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)
Douleur Neuropathique 4 questions DN4
the possibility of development of neuropathic pain will be assessed using DN4 scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03448315
Brief Title
Role of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management
Official Title
Role of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2, 2017 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
brain stimulation, tDCS, acute postoperative pain, chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
real tDCS
Arm Type
Active Comparator
Arm Description
motor cortex stimulation (2 mA, 20 min for 4 sessions)
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
motor cortex stimulation (2 mA, 20 min for 4 sessions) but stimulation device is turned off without the participant knowledge
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
motor cortex stimulation (2 mA, 20 min for 4 sessions)
Primary Outcome Measure Information:
Title
total morphine comsuption
Description
the total dose of morphine used as analgesic expressed in mg
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Visual analogue scale
Description
patient asked to describe this pain with scores ranging from 0 to10 (with 0 = no pain and 10 = the worst pain imaginable)
Time Frame
baseline,at 2,4,6, 12, 24,36,48 hours
Title
Douleur Neuropathique 4 questions DN4
Description
the possibility of development of neuropathic pain will be assessed using DN4 scale
Time Frame
1month, 3month, 6 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
South Egypt Cancer Institute
City
Assiut
ZIP/Postal Code
11715
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Role of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management
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