| CTRI Number |
CTRI/2023/11/060185 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
13/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
COMPARING TWO APPROACHES OF UPPER LIMB SURGERY NAESTHESIA:LATERAL AND SUBCLAVIAN PERIVASCULAR APPROACHES OF SUPRACLAVICULAR BRACHIAL BLOCK |
|
Scientific Title of Study
|
COMPARISON OF TWO APPROACHES OF SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB SURGERIES -LATERAL APPROACH AND SUBCLAVIAN PERIVASCULAR APPROACH |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HRIDYA DINESH |
| Designation |
PRIMARY DNB |
| Affiliation |
HINDU RAO HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA
HINDU RAO HOSPITAL
NEAR G BLOCK
GANDHI SQUARE
MALKA GANJ
DEPARTMENT OF ANAESTHESIA
HINDU RAO HOSPITAL
NEAR G BLOCK
GANDHI SQUARE
MALKA GANJ
North
DELHI
110007
India |
| Phone |
6282796071 |
| Fax |
|
| Email |
DRHRIDYANAND@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DHEERAJ PRAKASH GUPTA |
| Designation |
CMO(NFSG) |
| Affiliation |
HINDU RAO HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE,NDMC MEDICAL COLLEGE AND ASSOCIATED
HINDU RAO HOSPITAL
GANDHI SQUARE
MALKA GANJ
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE,NDMC MEDICAL COLLEGE AND ASSOCIATED
HINDU RAO HOSPITAL
GANDHI SQUARE
MALKA GANJ
North
DELHI
110007
India |
| Phone |
9873151754 |
| Fax |
|
| Email |
DRDHEERAJPGUPTA@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR DHEERAJ PRAKASH GUPTA |
| Designation |
CMO(NFSG) |
| Affiliation |
HINDU RAO HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE,NDMC MEDICAL COLLEGE AND ASSOCIATED
HINDU RAO HOSPITAL
GANDHI SQUARE
MALKA GANJ
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE,NDMC MEDICAL COLLEGE AND ASSOCIATED
HINDU RAO HOSPITAL
GANDHI SQUARE
MALKA GANJ
North
DELHI
110007
India |
| Phone |
9873151754 |
| Fax |
|
| Email |
DRDHEERAJPGUPTA@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| HINDU RAO HOSPITAL
GANDHI SQUARE,MALKA GANJ,DELHI
110007 |
|
|
Primary Sponsor
|
| Name |
HINDU RAO HOSPITAL |
| Address |
HINDU RAO HOSPITAL,GANDHI SQUARE,MALKA GANJ,DELHI
110007 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR HRIDYA DINESH |
HINDU RAO HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE MEDICINE,NDMC MEDICAL COLLEGE AND ASSOCIATED
HINDU RAO HOSPITAL
OPPOSITE TO G BLOCK
GANDHI SQUARE
MALKA GANJ
North
DELHI |
6282796071
DRHRIDYANAND@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V220||Motorcycle driver injured in collision with two- or three-wheeled motor vehicle in nontraffic accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK USING CLASSICAL APPROACH |
THE LATERAL APPROACH,WHICH IS A NEW APPROACH OF SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK, ,WE ARE COMPARING WITH THE CLASSICAL SUBCLAVIAN PERIVASCULAR APPROACH OF SUPRACLAVICULAR BLOCK |
| Intervention |
SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK USING LATERAL APPROACH |
THE LATERAL APPROACH,WHICH IS A NEW APPROACH OF SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK, ,WE ARE COMPARING WITH THE CLASSICAL SUBCLAVIAN PERIVASCULAR APPROACH |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I,II UNDERGOING ELECTIVE SURGERY OF HAND,WRIST,FORE ARM,ELBOW AND LOWER 1/3 RD OF ARM |
|
| ExclusionCriteria |
| Details |
PREGNANCY
INFECTION AT PUNCTURE SITE
COAGULOPATHY
ALLERGY TO AMIDE AND LOCAL ANAESTHETICS
CO EXISTING CLAVICULAR FRACTURE
SEVERE CARDIOPULMONARY COMPROMISE |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SUCCESS OF BLOCK |
30 MINUTES AFTER ADMINISTRATION OF BLOCK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ONSET OF SENSORY BLOCK AND DERMATOMES SPARED |
AT THE END OF 30 MINUTES OF BLOCK |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
19/12/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS A PROSPECTIVE INTERVENTIONAL DOUBLE BLINDED RANDOMISED CONTROL,SINGLE CENTRE TRIAL COMPARING THE SUBCLAVIAN PERIVASCULAR AND LATERAL APPROACHES OF SUPRACLAVICULAR BRACHIAL PLUXES BLOCK,WILL BE CONDUCTED IN THE ELECTIVE CASES OF UPPER LIMB SUGERIES BELOW HUMERUS IN HINDU RAO HOSPITAL.THE PRIMARY OUTOME MEASURE WILL BE THE SUCCESS RATE OF AT THE END OF 30 MINUTES OF BLOCK AND SECONDARY OUTCOME WILL BE ONSET OF SENSORY BLOCK AND DERMTAOME SPARED AT THE END OF 30 MINUTES |