Role of Transcrainal Direct Current Brain Stimulation in Acute and Chronic Post-mastectomy Pain Management
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started Dec 2017
Longer than P75 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2017
CompletedFirst Submitted
Initial submission to the registry
February 22, 2018
CompletedFirst Posted
Study publicly available on registry
February 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedOctober 19, 2020
October 1, 2020
1.3 years
February 22, 2018
October 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
total morphine comsuption
the total dose of morphine used as analgesic expressed in mg
48 hours
Secondary Outcomes (2)
Visual analogue scale
baseline,at 2,4,6, 12, 24,36,48 hours
Douleur Neuropathique 4 questions DN4
1month, 3month, 6 month
Study Arms (2)
real tDCS
ACTIVE COMPARATORmotor cortex stimulation (2 mA, 20 min for 4 sessions)
sham tDCS
SHAM COMPARATORmotor cortex stimulation (2 mA, 20 min for 4 sessions) but stimulation device is turned off without the participant knowledge
Interventions
Eligibility Criteria
You may qualify if:
- ASA I-II, scheduled for unilateral modified radical mastectomy with axillary dissection for breast cancer
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Egypt Cancer Institute
Asyut, 11715, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lectruer of anesthesia, ICU and pain manegement
Study Record Dates
First Submitted
February 22, 2018
First Posted
February 28, 2018
Study Start
December 2, 2017
Primary Completion
April 1, 2019
Study Completion
December 1, 2021
Last Updated
October 19, 2020
Record last verified: 2020-10