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CTRI Number  CTRI/2023/10/058720 [Registered on: 16/10/2023] Trial Registered Prospectively
Last Modified On: 16/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two approaches of continuous brachial plexus block among children undergoing elbow, forearm and hand surgeries. 
Scientific Title of Study   Comparison of analgesic efficacy and safety of Ultrasound guided infraclavicular brachial plexus blockade to a modified continuous costoclavicular block (Caudocranial RetroAxillary interFascial Transpectoral- CRAFT approach) in pediatric patients undergoing upper limb surgeries -A Randomized control trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VIMAL B 
Designation  PG REGISTRAR 
Affiliation  CMC VELLORE 
Address  DEPARTMENT OF ANAESTHESIA, CMC HOSPITAL,THOTTAPALYAM, VELLORE - 632004
DEPARTMENT OF ANAESTHESIA, CMC HOSPITAL,THOTTAPALYAM, VELLORE - 632004
Vellore
TAMIL NADU
632004
India 
Phone  7708013450  
Fax    
Email  vimale101@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  SAJAN P GEORGE 
Designation  PROFESSOR 
Affiliation  CMC VELLORE 
Address  DEPARTMENT OF ANAESTHESIA, CMC VELLORE - 632004
DEPARTMENT OF ANAESTHESIOLOGY CMC VELLORE
Vellore
TAMIL NADU
632004
India 
Phone  04162282105  
Fax    
Email  sajanpg@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Vimal B 
Designation  PG Registrar 
Affiliation  CMC Vellore 
Address  Department of Anaesthesiology CMC Vellore - 632004
Department of Anaesthesiology CMC Vellore - 632004
Vellore
TAMIL NADU
632004
India 
Phone  7708013450  
Fax    
Email  vimale101@gmail.com  
 
Source of Monetary or Material Support  
CMC VELLORE FLUID RESEARCH FUND, Vice Principal for Research, Research Office, 1st floor - Carman Block CMC Bagayam Campus, Vellore - 632002 
 
Primary Sponsor  
Name  CMC Vellore Hospital and College 
Address  Research office, 1st Floor - Carman Block, CMC Vellore College, Bagayam , Vellore-632002 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
VIMAL B  CMC Hospital VEllore  OR Rooms - Paul Brand Building, Department of Anaesthesia, CMC Hospital, Vellore - 632004
Vellore
TAMIL NADU 
04162282105

vimale101@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CMC VELLORE SILVER IRB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional continuous catheter technique for the infraclavicular brachial plexus block   Conventional continuous catheter technique for the infraclavicular brachial plexus block  
Intervention  Modified continuous costoclavicular block (caudocranial transpectoral approach)  Modified continuous costoclavicular block (caudocranial transpectoral approach) 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
1) Children aged 6 months-7years undergoing elbow, forearm, and hand surgeries.
2) ASA 1 and ASA 2 Patients.

 
 
ExclusionCriteria 
Details  Exclusion criteria:
1) Patients with severe systemic illness.
2) Patients with local infection at the injection site, bleeding diathesis.
3) Patients with known allergic reactions to local anesthetics. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Equal efficacy of post operative analgesia using the newer approach as measured by FLACC scores   Equal efficacy of post operative analgesia using the newer approach as measured by FLACC scores  
 
Secondary Outcome  
Outcome  TimePoints 
1) Safety – significant reduction in risk of inadvertent neurovascular injury.
2) Better catheter stability & tolerance.
3) Usage of minimal drug volumes.
 
6,24, 48 HOURS 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   16/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Infraclavicular brachial plexus block is a preferred regional anaesthetic modality in elbow, forearm and hand surgeries in pediatric patients. The conventional approach to infraclavicular block by using ultrasound is performed in supine position with arm abducted to 90 degrees and the needle is inserted from cranial to caudal direction at a point 1cm below and 1cm lateral to midpoint of clavicle through which the catheter is inserted and left insitu, the complications of these approach are vessel puncture (2-33%), neurological injuries and pneumothorax. This study aims at an alternative approach to the brachial plexus block which targets the brachial plexus components at the costoclavicular level and is equally effective. The neurovascular bundle will be approached from the inferolateral aspect. This will be achieved by the anesthesiologist standing facing the head end of the patient and the needle will be inserted from caudal to cranial direction. Pediatric patients undergoing elbow and forearm surgery will be recruited. The study participants will be randomly assigned to the conventional or new approach and the patients will be masked about the allocation. The random allocation will be done using sealed envelopes which will be opened just before painting and draping the patient for nerve block. Information on pain score in post operative period in first 6hrs, 24 and 48 hours will be measured using FLACC pain scale. Complications like neurological injury during procedure, neurological damage at 24 and 48 hours will be assessed. Amount and frequency of rescue analgesia administered will be compared. Median pain scores will be compared to test equivalence between approaches. Incidence of complications and mean duration of analgesia will be compared using percentages and measures of central tendency respectively.

 
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