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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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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2016/04/006853 |
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Date of registration:
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21-04-2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pediatric pain control study
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Scientific title:
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Ultrasound guided "Pecs" block for chemoport insertion in pediatric patients: A pilot study. - Pecs study |
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Date of first enrolment:
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01-07-2016 |
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Target sample size:
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39 |
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Recruitment status: |
Not Yet Recruiting |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13683 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Outcome Assessor Blinded
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Arunangshu Chakraborty
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Address:
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Tata Medical Center, 14 MAR (EW), Newtown, Kolkata 700156
700156
North Twentyfour Parganas, WEST BENGAL
India |
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Telephone:
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Email:
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dr.arunangshu@gmail.com |
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Affiliation:
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Tata Medical Center |
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Name:
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Arunangshu Chakraborty
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Address:
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Tata Medical Center, 14 MAR (EW), Newtown, Kolkata 700156
700156
North Twentyfour Parganas, WEST BENGAL
India |
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Telephone:
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Email:
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dr.arunangshu@gmail.com |
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Affiliation:
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Tata Medical Center |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients undergoing chemoport insertion- for chemotherapy for cancer treatment.
Exclusion criteria: platelet count less than 50,000
fever
local infection
non-consenting
malignancy involving thoracic wall
known allergy to local anaesthetic drug
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- malignancy
Health Condition 2: C531- Malignant neoplasm of exocervix
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Intervention(s)
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Intervention1: Ultrasound guided "Pecs" block: Ultrasound guided pecs block is a recently introduced regional anaesthesia technique in which local anaesthetic drug is injected in the plane between pectoralis major and minor muscles, with an aim of anaesthetizing the lateral and medial pectoral nerves that supply anterior chest wall.
Control Intervention1: Control: the patient will not recieve pecs block: the patients in the control arm will not recieve the pecs block- hence serving as comparator
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Primary Outcome(s)
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Pain scores in the post operative periodTimepoint: Pain scores in the post operative period
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Secondary Outcome(s)
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requirement of rescue analgesic (Fentanyl)Timepoint: 0-24 hrs in the post operative period
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Secondary ID(s)
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Pecs V 1.0
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Source(s) of Monetary Support
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Tata Medical Center
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Ethics review
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Status: Approved
Approval date: 07/07/2015
Contact:
TMC IRB
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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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