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CTRI Number  CTRI/2024/02/062198 [Registered on: 01/02/2024] Trial Registered Prospectively
Last Modified On: 29/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparison of two techniques of upper limb block in upper limb surgeries  
Scientific Title of Study   “A Comparison of ultrasound-guided vs peripheral nerve stimulator guided supraclavicular block in upper limb surgeries”  
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 Alpa patel 
Designation  Professor, department of anaesthesiology  
Affiliation  H M Patel center for medical care and education 
Address  Department of anesthesiology, H M Patel center for medical care and education Karamsad Anand Anand GUJARAT 388325 India

Anand
GUJARAT
388328
India 
Phone  9825084228  
Fax    
Email  alpamp@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vatsal parikh 
Designation  Resident doctor, department of anaesthesiology  
Affiliation  H M Patel center for medical care and education 
Address  Pg hostel,Karamsad Anand Anand GUJARAT 388325 India
C/26 meghdoot society,vrundavan cross roads ,waghodia road,vadodara
Anand
GUJARAT
390019
India 
Phone  8200643179  
Fax    
Email  vatsalparikh.vp@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR VATSAL PARIKH 
Designation  RESIDENT DOCTOR, DEPARTMENT OF ANAESTHESIOLOGY 
Affiliation  H M Patel center for medical care and education 
Address  Department of anaesthesiology,Karamsad Anand Anand GUJARAT 388325 India
Department of anaesthesiology
Anand
GUJARAT
390019
India 
Phone  8200643179  
Fax    
Email  vatsalparikh.vp@gmail.com  
 
Source of Monetary or Material Support  
Shree krishna hospital,karamsad 
 
Primary Sponsor  
Name  Shree krishna hospital,anand 
Address  Karamsad Anand Gujarat  
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 
DrVatsal parikh  Shree krishna hospital karamsad   Department of anaesthesiology,Karamsad Anand Gujarat
Anand
GUJARAT 
8200643179

vatsalparikh.vp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-2 Bhaikaka University,Karamsad,Anand, Gujarat- 388325  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S521||Fracture of upper end of radius,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patients ASA(american society of anaesthesia) I, II and III physical status
2)Age 18-70yrs of either sex
3)Patients undergoing upper limb surgery 
 
ExclusionCriteria 
Details  1) Patients refusal to regional anaesthesia
2) Skin infection located on or near block injection site
3) Allergy to local anesthetics
4) Presence of bleeding disorder or coagulopathy
5) Patients with preexisting neurological deficit of the same limb
6) Psychiatric disorder
7) Bilateral upper limb surgery
8) Severe chronic obstructive or restrictive lung disease
9) Requirement of conversion to general anaesthesia due to inadequate block 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Assess the efficacy & procedure duration in view of onset of sensory blockade in
supraclavicular block ultra sound guided vs peripheral nerve stimulator guided block.
Secondary outcome
1)to compare the two techniques of supraclavicular block in terms of Onset of sensory and
motor block.
2)to compare the two techniques of supraclavicular block in terms of Block success rate
3)To compare the hemodynamic parameters: Heart-rate, systolic & diastolic blood pressure, oxygen
saturation & complications like vascular punctures, pneumothorax, nerve palsies, hematoma formation
and infection at injection site.
 
10-20mins
 
 
Secondary Outcome  
Outcome  TimePoints 
1)to compare the two techniques of supraclavicular block in terms of Onset of sensory and
motor block.
2)to compare the two techniques of supraclavicular block in terms of Block success rate
3)To compare the hemodynamic parameters: Heart-rate, systolic & diastolic blood pressure, oxygen
saturation & complications like vascular punctures, pneumothorax, nerve palsies, hematoma formation
and infection at injection site.
 
5-15 mins 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   19/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/02/2024 
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 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   After obtaining ethical committee approval and obtaining written and informed consent, patients
of ASA (American society of anaesthesia) I to ASA III physical status who is undergoing elective orthopedic
surgeries the level below the shoulder and distally will be recruited to participate in study. It is a
observational study. Sixty patients will be devided randomly to either ultrasound guided vs peripheral nerve
stimulator guided the supraclavicular block using winpepi software.
Pre anaesthetic check up will be carried out in all patients with detailed clinical history, general
history, as well as general and systemic examination. After checking the overnight fasting of 6-8hours,
arrival to anaesthetic room, an i.v line, a blood pressure cuff and pulse oximetry probe will be attached to
non operated arm. All block will be performed by the 2nd and 3rd year resident with experience of
performing 10-15 blocks using ultrasound under the supervision of an experienced anesthesiologist. A
randomization envelope opened at this stage and the patient will be allocated to either group US or NS. All
block will be performed by the first anesthesiologist who will take no further part in that case management.
Sedation will be administered until the evaluation of the block is completed if required.
· After obtaining written informed consent from all subjects, 60 adult patients, who were American Society
of Anaesthesiology physical status I-III and scheduled for electiveor emergency upper limb surgery will be
studied prospectively.
· The study will be conducted in 2 years from october 2022 to october 2024.
· Total of 60 patients will be enrolled in this observational study and will be randomly divided into two
groups: US (Group US) and NS (Group NS).
All the patients will be fasted adequately. In the operation theatre, patients will be monitored with pulse
oximetry, non invasive blood pressure, and electro cardiogram. After establishing an intravenous access, the
patients received inj. midazolam 1 mg intravenously. No other sedation will be given till evaluation of the
block gets completed.
· The patients will be randomly allotted by closed envelope technique into either of the two groups namely,
US-guided (group US) or NS-guided (group NS). The respective equipment will be kept ready and the drugs
will be loaded maintaining sterility. The drug used will be a 1:1 mixture of 0.5% ropivacaine and 2%
lignocaine with 1:200000 adrenaline. The amount of local anaesthetic injected calculated according to the
body weight and not crossing the toxic dosage (inj. Ropivacaine 4 mg/kg, inj. lignocaine with adrenaline 7
mg/kg). The patients will be positioned supine with the arms by the side and head turned to the opposite side
by 45°. The proposed site of block will be aseptically prepared and draped.
Group US
The probe will be inserted into a sterile plastic sheath so as to maintain sterility. It will be placed in the
coronal oblique plane in the supraclavicular area. The subclavian artery, vein, and the brachial plexus will be
visualized. The brachial plexus and its spatial relationship to the surrounding structures will be scanned. The
plexus will be identified superolateral to the subclavian artery consistently in all the cases. Next, skin will be
anesthetized at the proposed site of entry with 2% lignocaine (2 mL) and a 20 G, 50 mm needle will be
connected to a 50 cm extension line and primed with the drug. It will be inserted from the lateral to medial
direction and the needle movement was observed in real time. Once the needle reached the plexus, after
negative aspiration, drug will be injected and the spread of the drug will 
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