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CTRI Number  CTRI/2025/03/082091 [Registered on: 10/03/2025] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Success Rate of two types of regional anaesthesia for upper limb surgeries. 
Scientific Title of Study   Comparison of Success Rate of the Classic Subclavian Perivascular approach with the Lower Interscalene approach of Supraclavicular Brachial Plexus block for upper limb surgeries- A Randomised 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  Pranati Yerramilli 
Designation  Postgraduate 
Affiliation  SRM Medical College Hospital and Research Center 
Address  Department of Anaesthesiology, SRM Medical College Hospital and Research Center, Potheri, Kattakulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9176370850  
Fax    
Email  pranatiyerramilli@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Venkatraman R 
Designation  Professor 
Affiliation  SRM Medical College Hospital and Research Center 
Address  Department of Anaesthesiology, SRM Medical College Hospital and Research Center, Potheri, Kattakulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9894581455  
Fax    
Email  drvenkat94@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Venkatraman R 
Designation  Professor 
Affiliation  SRM Medical College Hospital and Research Center 
Address  Department of Anaesthesiology, SRM Medical College Hospital and Research Center, Potheri, Kattakulathur


TAMIL NADU
603203
India 
Phone  9894581455  
Fax    
Email  drvenkat94@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical College and Research Center, Potheri, Kattankulathur, Kancheepuram, Tamil Nadu - 603203 
 
Primary Sponsor  
Name  SRM Medical College 
Address  SRM Medical College Hospital and Research Center, Potheri, Kattankulathur, Kancheepuram, 603203 
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 Pranati Yerramilli  SRM Medical College Hospital and Research Center  Room No 208 B,Department of Anaesthesiology, second floor, SRM Medical College Hospital and Research Center, Potheri, Kattankulathur, Kancheepuram, 603023
Kancheepuram
TAMIL NADU 
9176370850

pranatiyerramilli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Classic Subclavian Perivascular approach of Supraclavicular Brachial Plexus Block  Classic Subclavian Perivascular block given with 25ml 0.25% Ropivacaine and 50mcg Dexmetomidine under Peripheral Nerve Stimulator guidance and monitored upto 24 hours. 
Intervention  Lower Interscalene approach of Supraclavicular Brachial Plexus Block   Lower Interscalene Block will be given with 25ml 0.25% Ropivacaine with 50mcg Dexmetomidine under Peripheral Nerve Stimulator guidance and monitored upto 24 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA Grade I, II, III
Patients undergoing elective upper limb surgeries from below mid-arm.
Surgeries in supine position.
BMI: 18.5 – 24.9 
 
ExclusionCriteria 
Details  Patient refusal.
Contraindications to regional nerve block:
-Cellulitis/ infection at the local site.
-Coagulopathy.
-Allergy to local anaesthetic agents.
Patients with pre-existing nerve injury.
Patients with chest deformity.
Patients with clavicle fracture.
Pregnancy.
Surgeries requiring tourniquet application. 
 
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 
To compare success rate  The block is taken as successful when there is complete sensory blockade and surgery completed only
under regional block.
If one nerve is spared, a rescue block will be given.
If more than one nerve is spared, General anaesthesia will be administered.
These will be considered as failure of the block. 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken for onset of sensory and motor blockade  0 min
15 min
30 min 
Time taken to perform the block  The time interval between the first needle insertion and injection of the drug will be taken as the
procedure time. 
Number of attempts  The number of skin puncture made to perform the block will be noted. The maximum number will be
limited to three after which it will be abandoned. This will be taken as failure and proceeded to
alternative methods of anaesthesia. 
Incidence of complications such as: Vascular injections, pneumothorax, phrenic nerve palsy
and Horner’s syndrome 
Number of patients having complications such as vascular injections, pneumothorax, nerve injury,
phrenic nerve palsy, Horner’s syndrome 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="78" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   16/03/2025 
Date of Study Completion (India) 21/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
ï‚· After approval by the Institutional Scientific and Ethical Committee, and CTRI approval this
prospective, randomised and observer-blinded study will be done on n patients undergoing
elective upper limb surgeries of the elbow, forearm and hand in a tertiary medical college
hospital.
ï‚· The patients will be randomized to receive either Supraclavicular(Group S) or lower
Interscalene(Group I) blocks by computer-generated random numbers and closed-envelope
method.
ï‚· All the patients will be pre-medicated with Tab Alprazolam 0.5 mg orally before shifting to
the operation theatre. A Randomisation envelope will be opened at this stage and the patient
allocated to either Group I or S.
ï‚· All the blocks will be performed by the anaesthesiologist with experience of performing 10-
30 blocks using both ultrasound and nerve stimulator under the supervision of an experienced
anaesthesiologist and will not take no further part in that case management.
ï‚· All the blocks will be performed with 25 mL 0.5% Ropivacaine and 50mcg Dexmetomidine.
Nerve Stimulator – STIMPOD NMS450, XAVANT Technology, model no XT-45021; B
Braun 50mm stimuplex needle
ï‚· The second anaesthesiologist who will be blinded to the type of block given will monitor all
the study parameters and decide on further management of the patient.

GROUP S
ï‚· The supraclavicular block will be performed with the patient in supine position and the head
tilted to the opposite side, and the skin will be disinfected and draped.
ï‚· In this group, the positive electrode from the peripheral nerve stimulator (PNS) is attached to
an ECG lead and placed on the ipsilateral arm, and the negative electrode is attached to the
50mm stimuplex needle. After skin preparation, the subclavian artery is palpated in the
supraclavicular region and skin is infiltrated with 2% lignocaine immediately lateral to the
artery. The point of needle entrance is about one inch lateral to the artery. The needle is
inserted through the skin in a downward, inward and posterior direction with the PNS set to
deliver 1mA current at 1 Hz frequency and 0.1 ms of pulse duration. The needle is slowly
advanced until muscle twitch (elbow/wrist/ finger flexion/extension) is obtained. Once the
finger twitch is obtained, the current is gradually reduced to 0.4 mA and then the local
anaesthetic solution is injected after negative aspiration. If muscle twitch is present even at
0.2mA , it indicates that the needle is inside the nerve sheath.

GROUP I
ï‚· The lower interscalene block will be performed with the patient in supine position and the
head tilted to the opposite side, and the skin will be disinfected and draped.
ï‚· In this group, the positive electrode from the PNS is attached to an ECG lead and placed in
the ipsilateral shoulder, and the negative electrode is attached to a 50mm stimuplex needle.

ï‚· For LISB, the distance between C6 and the clavicle is divided into 3 equal parts. Skin is
infiltrated with 2% lignocaine and the needle inserted at two-thirds of this distance caudally
from C6.
ï‚· The needle is inserted at the lowest point on the interscalene groove in a downward, inward
and posterior direction with the PNS set to deliver 1mA current at 1 Hz frequency and 0.1 ms
of pulse duration.
ï‚· The needle is slowly advanced until muscle twitch (elbow/wrist/ finger flexion/extension ) is
obtained. Once the finger twitch is obtained, the current is gradually reduced to 0.5 mA and
then the local anaesthetic solution is injected after negative aspiration. If muscle twitch is
present even at 0.2mA , it indicates that the needle is inside the nerve sheath.

Sensory evaluation for pain and touch will be done for the entire cutaneous innervation of upper
limb,( 5 nerves)i.e., musculocutaneous, radial, ulnar, median, medial cutaneous nerves of forearm.
The sensory block in each dermatome will be evaluated using the following scale:

• 2 – normal sensation
• 1 – hypoesthesia
• 0 – no sensation felt

Motor block will be assessed after injection of the drug according to modified Bromage scale for
upper extremities. Flexion, extension, abduction will be checked at the elbow, wrist, and fingers.
Modified Bromage grade to assess upper limb motor weakness:

• Grade 0: Normal motor function with full extension of elbow, wrist, and fingers
• Grade 1: Ability to flex and extend wrist and fingers
• Grade 2: Ability to flex and extend only fingers
• Grade 3: Complete motor block with the inability to move elbow, wrist, and finger.
The onset and degree of sensory and motor block will be observed every 5 min for 30 min till
complete blockade is achieved.
 
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