FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083505 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing sequential drug delivery for nerve block between one dug and two drugs 
Scientific Title of Study   Sequential Administration Of Dual Or Single Injection Of Local Anaesthetic For Continuous Infraclavicular Block-Does It Make A Difference?-A Randomized Controlled 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  Kousalya G 
Designation  Post doctoral fellowship 
Affiliation  Christian Medical College,Vellore 
Address  Department of Anaesthesia, Christian Medical College

Vellore
TAMIL NADU
632004
India 
Phone  8124320960  
Fax    
Email  gkousalya53@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Serina ruth salins 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Professor and Head of Unit-II, Department of Anaesthesia, Christian Medical College

Vellore
TAMIL NADU
632004
India 
Phone  9442307738  
Fax    
Email  serina.ruth@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Serina ruth salins 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Professor and Head of Unit-II, Department of Anaesthesia, Christian Medical College

Vellore
TAMIL NADU
632004
India 
Phone  9442307738  
Fax    
Email  serina.ruth@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Christian medical college, Vellore-632004, Tamilnadu, India. 
 
Primary Sponsor  
Name  Christian medical college 
Address  Christian medical college, Vellore-632004 Tamilnadu, India. 
Type of Sponsor  Private 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 Kousalya G  Christian medical college  Department of Anaesthesia, 7th floor, New paul brand building, Christian medical college, Vellore-632004, India.
Vellore
TAMIL NADU 
8124320960

gkousalya53@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board, Office of research, Christian medical college, Vellore, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  comparing sequential administration of ropivacaine alone with lignocaine and ropivacaine for nerve block  comparing sequential administration of 10ml 0.5% ropivacaine and 10 ml 0.5% ropivacaine with 10ml 1% lignocaine and 10 ml 0.5% ropivacine for infraclavicular nerve block using peripheral nerve block needle with single injection and assess the onset and duration of sensory and motor blockade.onset of sensory blockade and motor blockade is assessed in minutes until complete loss of sensory and motor blockade occurs duration of sensory and motor blockade is assessed every 2 hours till 24 hours and every 4 hours till 24 hours  
Intervention  comparing sequential administration of ropivacaine alone with lignocaine and ropivacaine for nerve block  For continuous infraclavicular nerve block sequential administration of local anaesthetic is done Group A receives 0.5% ropivacaine 10 ml followed by a 20 seconds pause another 0.5% ropivacaine 10 ml is given using peripheral nerve block needle with single injection Group B receives 1% lignocaine 10ml followed by a 20 seconds pause 0.5% ropivacaine 10ml is given The total duration of procedure can take 15 minutes Assessment of onset of sensory and motor blockade and duration of block, complications. onset of sensory blockade and motor blockade is assessed in minutes until complete loss of sensory and motor blockade occurs duration of sensory and motor blockade is assessed every 2 hours till 24 hours and every 4 hours till 24 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with ASA I, II, III undergoing elective below-elbow and hand surgery
aged between 18-75years
Either sex
 
 
ExclusionCriteria 
Details  patient with significant neurological, psychiatric, or neuromuscular disease
suspected coagulopathy
morbid obesity
chronic renal failure
cardiopulmonary compromise
cerebral vascular disease
local infection at the site of the infraclavicular block
pregnant women and children 
 
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 
onset of sensory blockade
onset of motor blockade
duration of sensory blockade
duration of motor blockade 
sensory onset is assessed in minutes every 30 seconds until achieved
motor onset is assessed in minutes every 5 minutes until achieved
duration of sensory and motor blockade is assessed every 2 hours till 12 hours and every 4 hours till 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
intraoperative use of analgesics & complications  baseline 
 
Target Sample Size   Total Sample Size="174"
Sample Size from India="174" 
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)   01/04/2025 
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="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  

Local anaesthetic drugs are classified according to the duration of action as short, intermediate and long-acting drugs. Combining different classes of local anaesthetic drugs for peripheral nerve blocks has faster onset and prolonged duration of action. The purpose of this double blinded randomized controlled study is to compare onset and duration of action between sequential administration of one drug and a mixture of two different drugs , in terms of onset and duration, however, the same pharmacological groups of local anaesthetic drugs, for ultrasound guided infraclavicular approach with to brachial plexus block. An infraclavicular approach to the brachial plexus block can be used for surgical procedures below the mid humerus. It has gained popularity because of its ease of performance and the ability to simultaneously anaesthetize the axillary, musculocutaneous, median, radial and ulnar nerves. The block can be done with minimal risk of pneumothorax and other complications such as block of the phrenic nerve or stellate ganglion. An infraclavicular approach to brachial plexus block provides sufficient anaesthetic and analgesic effect for below-elbow and hand surgeries. Infraclavicular approach is not only advantageous for inserting a perineural catheter, but also has a short procedure time compared to other approaches including supraclavicular and axillary approaches especially using ultrasound guidance

Group A- will receive 10ml 0.5% Ropivacine+10 ml 0.5% Ropivacaine

Group B- will receive 10ml 1% Lignocaine+10 ml 0.5% Ropivacaine

Post procedure the onset of block is assessed by recording the sensory and motor blockade by time to complete loss of sensation and complete loss of motor power, need for intraoperative surgical anaesthesia and analgesia, is recorded and duration of block is assessed by time to rescue analgesia.

 

 
Close