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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03005548 |
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Date of registration:
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24/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cortical Modulation of Acute Post-thoracotomy Pain With Transcranial Direct Current Stimulation
CMAPTPtDCS |
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Scientific title:
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Cortical Modulation of Acute Post-thoracotomy Pain With Transcranial Direct Current Stimulation |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03005548 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Serbia
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Contacts
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Name:
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Tihomir V Ilic, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Military Medical Academy |
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Name:
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Dusica M Stamenkovic, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Military Medical Academy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject is willing and able to provide written informed consent,
- Subject is 18-80 years old,
- Subject needs thoracotomy for confirmed malignant lung disease,
- Subject is extubated in the operating room
Exclusion Criteria:
- Subject is pregnant
- Subject is in treatment for psychiatric disease
- Subject is in treatment for neurological disease
- Subject is in treatment for chronic pain
- Subject has history of current or past alcohol or Street Drug abuse
- Subject has received chemotherapy
- Subject has history of previous thoracic or cardiac surgery
- Subject is allergic to medications that will be used in the study
- Subject has pacemaker or automatic implantable cardioverter/defibrillator
- Subject has implants or any other devices in the head, the spinal cord or peripheral
nerves
- Subject has confirmed brain lesion, including tumor or metastasis
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pain, Postoperative
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Intervention(s)
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Device: Transcranial direct current stimulation
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Drug: Morphine
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Primary Outcome(s)
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Amount of morphine used for treatment of pain after thoracotomy in a group of patients receiving tDCS combined with intravenous morphine PCA compared with a group of patients receiving sham stimulation combined with intravenous morphine PCA.
[Time Frame: Five days]
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Secondary Outcome(s)
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Pain scores measured using visual analogue scale (VAS) at rest, during movement and during cough in patients receiving tDCS combined and IV morphine PCA compared with patients receiving sham stimulation and IV morphine PCA.
[Time Frame: Five days]
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Secondary ID(s)
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MF-VMA// 07.12.2015.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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