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CTRI Number  CTRI/2024/09/073645 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 03/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of neural blockade type of Anaesthesia intervention in two group of patients 
Scientific Title of Study   Ultrasound-Guided crosswise approach of Popliteal sciatic Block Through a Common Paraneural Sheath Versus separate Injections at Tibial and Common peroneal nerve sheaths on Diabetic foot surgery patients: A Prospective, Randomized, Double blind Study  
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.Azhahiriraja K 
Designation  Post graduate  
Affiliation  Ganga medical centre and Hospital 
Address  Ganga Medical Centre 313 , Mettuppalayam road , Saibaba colony , Coimbatore 641038

Coimbatore
TAMIL NADU
641038
India 
Phone  8883338830  
Fax    
Email  azhahiriraja@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.G.Venkateswaran 
Designation  Senior consultant  
Affiliation  Ganga medical centre and hospitals 
Address  Ganga Medical Centre 313 , mettuppalam road , saibaba colony , Coimbatore 641038

Coimbatore
TAMIL NADU
641043
India 
Phone  9486661892  
Fax    
Email  venkatbharathi2005@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.G.Venkateswaran 
Designation  Senior consultant  
Affiliation  Ganga medical centre and hospitals 
Address  Department of Anaesthesiology Ganga Medical Centre 313 , Mettuppalayam Road , Saibabacolony ,Coimbatore

Coimbatore
TAMIL NADU
641043
India 
Phone  9486661892  
Fax    
Email  venkatbharathi2005@gmail.com  
 
Source of Monetary or Material Support  
Ganga medical centre and hospitals 313 , Mettuppalayam road saibaba colony , coimbatore - 641038 
 
Primary Sponsor  
Name  Ganga medical centre and hospitals 
Address  313 Mettupalayam road Saibaba colony Coimbatore - 641038 
Type of Sponsor  Private hospital/clinic 
 
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 Venkateswaran  Ganga medical centre and hospitals  4th Floor OT Complex Department of Anaesthesia
Coimbatore
TAMIL NADU 
9486661892

venkatbharathi2005@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board Department Of Anaesthesia Ganga medical centre and Hospital Private Limited   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  CAPS  ultra sound guided popliteal sciatic block - seperate injection through tibial and common peroneal nerve sheaths 
Intervention  Crosswise approach of popliteal sciatic block  Ultrasound guided crosswise approach of popliteal sciatic block through common paraneural sheath 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  •Diabetic Patients coming with non healing ulcer over foot and ankle
•Patients of ASA physical status I, II & III.
•Patients who are oriented to give consent.
 
 
ExclusionCriteria 
Details  •Patient refusal
•Patients of ASA physical status IV
•Known hypersensitivity to local anaesthetic drugs.
•Patients who are not oriented to give consent.
•Head injury and alcohol abuse patients.
•Patients with bleeding diathesis
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Sensory and Motor Onset of Nerve block  30 Minutes 
 
Secondary Outcome  
Outcome  TimePoints 
heart rate,blood pressure,map,saturation changes  5 , 10 ,15 ,20 minutes 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   16/09/2024 
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  

The blockade of the sciatic nerve in the popliteal fossa is a common technique used to provide regional anaesthesia and analgesia for surgeries involving the foot and ankle. With the advent of ultrasound for performing nerve blocks, it has greatly reduced the chances of block failure.

                       There is reduction in the volume of local anaesthetic with real time visualization of the drug spread. Positioning the patient may not be always possible. The aim of the present study was to evaluate the hypothesis that crosswise approach of popliteal sciatic nerve blockade through common paraneural sheath results shorter onset time when compared with post bifurcation injection external to the paraneural tissue

 MATERIALS AND METHODS:

                After obtaining the institutional ethical committee approval, 80 ASA I II and III patients who met the inclusion criteria were selected and randomly divided into 2 groups of 40 each.

                GROUP A patients received single injection of ultrasound- guided crosswise approach of popliteal sciatic block at the site of bifurcation through a common peroneal sheath 

               GROUP B patients received ultrasound- guided crosswise approach of popliteal sciatic blockade 2 separate circumferential injections of the tibial and common peroneal nerves distally to sciatic nerve.

                In both groups , The comfort of the patient with respect to positioning, The onset of sensory block (in minutes), the onset of motor block, and any complications also documented.

 
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