FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/01/048735 [Registered on: 04/01/2023] Trial Registered Prospectively
Last Modified On: 02/01/2023
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   Comparison of two different approach to popliteal sciatic nerve block using Ultrasound 
Scientific Title of Study   "Comparision of ultrasound guided Posterior Approach versus Crosswise Approach to Popliteal Fossa Block for postoperative analgesia in adult patients undergoing below knee surgeries:A pilot study" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NIDHI SINGH 
Designation  FELLOW IN REGIONAL ANAESTHESIA AND TRAUMA ANAESTHESIA. 
Affiliation  GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED. 
Address  DEPARTMENT OF ANAESTHESIA,GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED

Coimbatore
TAMIL NADU
641043
India 
Phone  8861514064  
Fax    
Email  singhnidhisakarwar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  NIDHI SINGH 
Designation  FELLOW IN REGIONAL ANAESTHESIA AND TRAUMA ANAESTHESIA. 
Affiliation  GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED. 
Address  DEPARTMENT OF ANAESTHESIA,GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED

Coimbatore
TAMIL NADU
641043
India 
Phone  8861514064  
Fax    
Email  singhnidhisakarwar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  TUHIN MISTRY 
Designation  JUNIOR CONSULTANT 
Affiliation  GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED. 
Address  DEPARTMENT OF ANAESTHESIA,GANGA MEDICAL CENTRE AND HOSPITAL PRIVATE LIMITED.

Coimbatore
TAMIL NADU
641043
India 
Phone  8240823526  
Fax    
Email  dr.tuhin2014@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  GANGA HOSPITAL 
Address  313, METTUPALAYAM ROAD, COIMBATORE PIN-641043 
Type of Sponsor  Research institution and hospital 
 
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 
Tuhin Mistry  Ganga Hospital  Department of Anaesthesiology, Ganga Hospital. 313, Mettupalayam Road, Coimbatore
Coimbatore
TAMIL NADU 
8240823526

dr.tuhin2014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SCIENTIFIC REVIEW BOARD,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  Crosswise Approach to popliteal sciatic nerve block after surgery  Performance of ultrasound guided Crosswise Approach to popliteal sciatic nerve block after surgery Total duration of study 24 hours 
Intervention  Supine posterior approach of popliteal sciatic nerve block  Performance of ultrasound guided Supine posterior approach of popliteal sciatic nerve block after surgery Total duration of study 24 hrs 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details 
Pt belonging to ASA grade 1 and ASA grade 2.
Patients posted for various elective below knee surgical procedure under General Anaesthesia or regional anaesthesia.
 
 
ExclusionCriteria 
Details  Any contraindications to popliteal sciatic block like local skin pathology, bleeding disorder, or patients on anticoagulants.
Patients not willing to participate in the study.
Patients with neurological deficit in the lower limb.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the ease of visualization of the sciatic nerve and its relation to the popliteal vessels. To compare the time taken for performing the block and duration of analgesia.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of analgesia, Onset of sensory and motor block, Patient and anaesthesiologists satisfaction scores  4 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   05/01/2023 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The popliteal sciatic nerve block (PSNB) is the most common practiced regional anaesthesia (RA) technique to provide anaesthesia or analgesia for foot and ankle surgery. To provide complete analgesia or anaesthesia below knee, popliteal sciatic blockade should be used together with a femoral or saphenous nerve block.

The sciatic nerve can be blocked at various levels. The popliteal sciatic block can be performed using landmark-PNS guided or under ultrasound guidance.

The use of ultrasound allows direct visualisation of the nerves and local anaesthetic spread with reduction in volume of local anaesthetic and hence improves the chances of successful nerve blockade.

Proper positioning of the patient is the key for better visualisation of the anatomical structures. Positioning the patient may not be always possible due to various reasons such as haemodynamic instability ,painful limb movements or misalignment of non-stabilised fracture segments ,poor cooperation of patient.Hence different approaches for performing the block are studied.The main objective of this study is to  compare the ultrasound guided posterior and Cross wise approach to popliteal sciatic block for surgeries involving the foot and ankle procedure in adult patients.

 
Close