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CTRI Number  CTRI/2011/07/001876 [Registered on: 12/07/2011] Trial Registered Retrospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two types of needles to perform above clavicle nerve block for doing forearm and hand surgeries 
Scientific Title of Study   To determine efficacy of supraclavicular brachial plexus block using blunt versus short bevel needle: a prospective randomized double blind 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  Dr Vanita Ahuja 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32  
Address  Dr Vanita Ahuja Assistant Professor Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160032
India 
Phone  9815496989  
Fax    
Email  vanitaanupam@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vanita Ahuja 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32  
Address  Dr Vanita Ahuja Assistant Professor Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 Chandigarh


CHANDIGARH
160032
India 
Phone  9815496989  
Fax    
Email  vanitaanupam@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vanita Ahuja 
Designation  Assistant Professor 
Affiliation  Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32  
Address  Dr Vanita Ahuja Assistant Professor Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 Chandigarh


CHANDIGARH
160032
India 
Phone  9815496989  
Fax    
Email  vanitaanupam@yahoo.co.in  
 
Source of Monetary or Material Support  
Government Medical College and Hospital Sector 32 Chandigarh 
 
Primary Sponsor  
Name  Dr Vanita Ahuja  
Address  Assistant Professor Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 Chandigarh  
Type of Sponsor  Government medical college 
 
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 Vanita Ahuja   Department of Anaesthesia and Intensive Care   Government Medical College and Hospital Sector 32 Chandigarh
Chandigarh
CHANDIGARH 
09646121649

vanitaanupam@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Government Medical College and Hospital Sector 32 Chandigarh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S424||Fracture of lower end of humerus, Onset and efficacy of regional anaesthesia; supraclavicular nerve block ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Supraclavicular brachial plexus block under ultrasound guidance using 20 G short bevel needle  The block effect will be assessed by an independent observer every 5 minutes in individual nerve territories both motor and sensory till the attainment of block or to a maximum of 60 minutes 
Comparator Agent  Supraclavicular brachial plexus block under ultrasound guidance using 20 G Touhy needle  The block effect will be assessed by an independent observer every 5 minutes in individual nerve territories both motor and sensory till the attainment of block or to a maximum of 60 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American society of anesthesiologist (ASA) I–II
below elbow surgeries
 
 
ExclusionCriteria 
Details  patient refusal
known neuropathy involving the arm undergoing surgery
mental incapacity
body mass index more than 35 kg/m2
known allergy to local anesthetics
local infection
coagulopathy
fasting less than 8 hours
any other contraindication to peripheral nerve blocks
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary aim of this study will be to determine the efficacy of individual nerve blocks using blunt versus short bevel needle under ultrasound guidance for placement of supraclavicular brachial block for below elbow surgeries. Assuming that establishment of sensory and motor block occurs in 30 minutes and show a difference of 5.0 minutes will be significant for successful surgical block.
 
02 years 
 
Secondary Outcome  
Outcome  TimePoints 
Block performance time, procedure related pain, ideal block evaluation time, nerve block supplementation and early neurological sequel   02 years 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   06/06/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  
Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Supraclavicular brachial plexus block is being routinely performed under ultrasound guidance for below elbow surgeries .It has many advantages as it allows the operator to visualize the needle and surrounding structures, minimizes the risk of contact with the pleural dome, and subclavian artery, decrease procedural times and increases block success .This study is a prospective ,randomized, double blind, single-centre trail to determine efficacy of supraclavicular brachial plexus block using blunt versus short bevel needle. A written informed consent from 60 patients American society of anesthesiologist (ASA) I�II, between 18 -60 years, of either sex, undergoing below elbow surgery will taken up for the clinical trial. The primary outcome measures will be efficacy of individual nerve blocks using blunt versus short bevel needle for supraclavicular block. The block effect will be assessed by an independent observer every 5 minutes in individual nerve territories both motor and sensory till the attainment of block or to a maximum of 60 minutes. Secondary outcome will be block performance time, procedure related pain, ideal block evaluation time, nerve block supplementation and early neurological sequel.

 

 
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