| 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 |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Comparison of the two techniques of Costoclavicular block used for pain relief after hand surgery in children |
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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 |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences New Delhi, New Delhi 110029,India |
|
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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 |
|
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,AIIMS, New Delhi |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M249||Joint derangement, unspecified, |
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Intervention / Comparator Agent
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| 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. |
|
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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
|
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| 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
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| 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.
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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
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Secondary Outcome
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| Outcome |
TimePoints |
To compare the ease of needling between the two groups
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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. |
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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" |
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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 |
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Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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