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CTRI Number  CTRI/2024/11/077084 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 15/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of the two techniques of Costoclavicular block used for pain relief after hand surgery in children  
Scientific Title of Study   Comparison of Ultrasound guided out-of-plane vs in-plane Costoclavicular block approach in children undergoing unilateral upper extremity surgery- A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajashree Deka 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences  
Address  Room no.5011, Academic block, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi, Ansari nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9967713827  
Fax    
Email  dekarajashree1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shreya Bharat Shah  
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences  
Address  Room No.5011, Academic Block, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi, Ansari nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9892652781  
Fax    
Email  shreyabs@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajashree Deka 
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences  
Address  Room no.5011, Academic block, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi, Ansari nagar, New Delhi

New Delhi
DELHI
110029
India 
Phone  9967713827  
Fax    
Email  dekarajashree1996@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences New Delhi, New Delhi 110029,India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Room no 5011, Academic Block, Department of Anaesthesiology, Pain Medicine and Critical care, AIIMS New Delhi, Ansari Nagar, New Delhi  
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 
Dr Rajashree Deka   All India Institute of Medical Sciences New Delhi   Room No.5011, Academic Block, Department of Anaesthesiology. Pain Medicine and Critical care, AIIMS New Delhi, Ansari Nagar
New Delhi
DELHI 
9967713827

dekarajashree1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee,AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M249||Joint derangement, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group IP- In-plane approach to ultrasound guided costoclavicular block  Group IP- Under ultrasound guidance, 0.3 mL/kg of 0.2% ropivacaine will be injected during the performance of costoclavicular block  
Comparator Agent  Group OP- Out-of-plane approach to ultrasound guided costoclavicular block   Group OP- Under ultrasound guidance, 0.3 mL/kg of 0.2% ropivacaine will be injected during the performance of costoclavicular block. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Children between 2 to 10 years of age
2. Scheduled for unilateral surgery of elbow, forearm, wrist or hand under general anesthesia
3. ASA physical status I/II
 
 
ExclusionCriteria 
Details  1. Patients requiring simultaneous contralateral upper extremity surgery or skin/bone grafting
2. Preexisting neurological deficit
3. History of previous surgery or trauma at the block area
4. Local site infection
5. H/O known allergy to local anaesthetics
6. Bleeding diathesis
7. Refusal of consent/assent
8. ASA physical status III/IV

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the mean needling time in out-of-plane and in-plane approaches of ultrasound guided costoclavicular brachial plexus block for upper limb surgeries in paediatric patients aged 2 to 10 years.

 
At time points 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes during the performance of ultrasound guided costoclavicular block

 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the ease of needling between the two groups
 
At time points 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes during performance of ultrasound guided costoclavicular block

 
To compare number of skin punctures between the two groups  At time points 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes during performance of ultrasound guided costoclavicular block



 
To compare the number of needle manipulations to obtain a complete local anaesthetic spread between the two groups  At time points 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes during performance of ultrasound guided costoclavicular block


 
To compare the success rate that is absence of increase in heart rate or blood pressure more than 20 percent from baseline during skin incision between the two groups  At time points 15,20,25,30 minutes during performance of ultrasound guided costoclavicular block
 
To compare the postoperative pain scores between the two groups  In PACU on arrival,5mins,30mins,2hrs,6hrs after arrival to the postoperative room 
To compare the duration of postoperative analgesia between the two groups  In PACU at time points 15,30,45,60,75,90 minutes & every 15 minutes till 6hrs postoperatively. 
To compare the complications between the two groups  At time points 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 minutes during performance of costoclavicular block through intraoperative period,in postoperative period every 15minutes till 6hrs. 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 3 
Date of First Enrollment (India)   02/12/2024 
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="2"
Months="0"
Days="0" 
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   Patients fulfilling the inclusion criteria will be confirmed by anaesthesiologist during pre Anesthetic checkup. Patients will be randomised into one of the two groups based on the approach to the costoclavicular block IN PLANE or OUT OF PLANE using computer generated random number table. Group allocation will be carried out using sealed enveloped technique.
Under aspectic precautions the ultrasound probe will be placed inferior and parallel to the clavicle to obtain the view of costoclavicular space. From medial to lateral, beneath the subclavius muscle a clear Image of axillary vein artery and brachial plexus cords will be considered as ideal for perineal injection . A 22G 5cm needle will be attached to the nerve simulator. 
In IP group after identifying the costoclavicular space the needle will be advanced in plane from lateral to medial side aiming to enter the sheath of brachial plexus. 
In OP group after identifying the costoclavicular space the needle will be advanced out of plane through the pectoralis muscle and subclavius with watch on the plural to enter the sheath of brachial plexus.
In both the groups the proximity to the cords will be identified based on the motor response to nerve stimulation and 0.5 ML per KG of 0.2 percent ropivacaine will be injected after negative aspiration of blood.
Surgeons will be requested to make the skin incision after 20 minutes of administration of the block. A rise in heart rate/BP more than 20 
Percent will be considered as block failure and one microgram per KG of fentanyl will be administered intravenously. 
In the PACU Post operative pain will be assisted using FLACC score  in children less than seven years and vAS  pain score in children. more than seven years. Pain will be assisted on arrival and in 15 minutes 30 minutes two hours six hours after arrival to the PACU.
In this study the  primary outcome will be measured by the needling time which is the time taken from skin puncture to obtaining an acceptable motor response at 0.5 mA on peripheral nerve locator. 


 
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