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CTRI Number  CTRI/2024/01/061926 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 31/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Ankle block performed with Ultrasound to without ultrasound ( Landmark method) and also studying the course of ankle nerves on ultrasonography and its distance from the landmarks.  
Scientific Title of Study   Ultrasound guided versus Landmark guided Ankle block and sono-anatomical correlation of ankle nerves with landmarks- Prospective randomized single 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  SUSHANT PANDURANG BHABAL 
Designation  Senior Registrar 
Affiliation  Ruby Hall Clinic  
Address  Ruby Hall Clinic, Department of Anaesthesia 7th Floor 40 Sasoon Rd, Sangamwadi, Pune Maharashtra
40, Sasoon road, sangamwadi pune,Maharashtra
Pune
MAHARASHTRA
411001
India 
Phone  8928814179  
Fax    
Email  sushantbhabal05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SUSHANT PANDURANG BHABAL 
Designation  Senior Registrar 
Affiliation  Ruby Hall Clinic  
Address  Ruby Hall Clinic, Department of Anaesthesia 7th Floor 40 Sasoon Rd, Sangamwadi, Pune Maharashtra
40, Sasoon road, sangamwadi pune,Maharashtra
Pune
MAHARASHTRA
411001
India 
Phone  8928814179  
Fax    
Email  sushantbhabal05@gmail.com  
 
Details of Contact Person
Public Query  
Name  SUSHANT PANDURANG BHABAL 
Designation  Senior Registrar 
Affiliation  Ruby Hall Clinic  
Address  Ruby Hall Clinic, Department of Anaesthesia 7th Floor 40 Sasoon Rd, Sangamwadi, Pune Maharashtra
40, Sasoon road, sangamwadi pune,Maharashtra
Pune
MAHARASHTRA
411001
India 
Phone  8928814179  
Fax    
Email  sushantbhabal05@gmail.com  
 
Source of Monetary or Material Support  
Ruby Hall Clinic Multispecialty Hospital, Pune Maharashtra.  
 
Primary Sponsor  
Name  Ruby Hall Clinic  
Address  40, Sasoon Rd, Sangamwadi Pune Maharashtra 411001 
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 
Dr Nita Dsouza   Ruby Hall Clinic   7th Floor Department of Anesthesia 40, Sasoon Rd , Sangamwadi Pune 411001
Pune
MAHARASHTRA 		 9823721982

drnita610@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical and Health Research - Poona Medical Research Foundation   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  Group L: Landmark guided Ankle block   Ankle block will be performed by traditional landmark guided technique to block tibial, Superficial and deep peroneal, saphenous and sural nerves. Local Anesthetic solution total of 30ml consisting of 10 ml Inj Ropivacaine 0.75% + 10ml Inj Lignocaine+adrenaline 2%+ 10ml sterile Normal saline will be given to perform the block. Time of performing the block will be noted from once the needle enters the skin for 1st nerve block till the blocking of 5th nerve is completed this time will be noted. Duration of Analgesia and patient satisfaction score will be noted. Duration to perform block will be noted rough estimation will be 20min prior surgery. Then followup duration will be 24hrs post surgery  
Comparator Agent  Group U : Ankle block procedure will be performed under ultrasonography guidance   Ankle nerves will be visualized under ultrasonography guidance and local anesthetic will be deposited to block tibial, Superficial and deep peroneal, saphenous and sural nerves. Local Anesthetic solution total of 30ml consisting of 10 ml Inj Ropivacaine 0.75% + 10ml Inj Lignocaine+adrenaline 2%+ 10ml sterile Normal saline will be given to perform the block. Time of performing the block will be noted from once the needle enters the skin for 1st nerve block till the blocking of 5th nerve is completed this time will be noted. Duration of Analgesia and patient satisfaction score will be noted. Duration to perform block will be before surgery and follow up period will be post op day 1  
Intervention  proximal tracing of Ankle nerves   Using ultrasonography to scan the Tibial nerve, Saphenous nerve, Deep and superficial peroneal nerve, sural nerve which are commonly blocked in an ankle block. Using the ultrasound the course of these nerves will be traced proximal upwards in leg to find out the distances till which nerves can be easily seen and the measurement will be taken from fixed landmark points like Lateral and medial malleolus and intermalleolar line. duration to perform ultrasound scan will be 3-5min  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patient who can communicate and are well oriented who are scheduled for elective foot surgery
2. Age between 18-70years 3. Those who are willing to participate in study 4. American society of anesthesiologist physical status I - III 
 
ExclusionCriteria 
Details  1) Patients not willing for participation in study 2) Age Ë‚ 18 or >70 years; 3) Known preexisting neuropathies/parasthesia 4) Known impaired cognitive function; 5) Pregnanancy; 6) Chronic use of opioids; 7)
Intolerance for local anesthetics and non-steroidal anti-inflammatory drugs (NSAID); 8) Redo surgery. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Analyse the effectiveness of Ultrasound guided vs Landmark
guided ankle block in terms of
1.Ease of performance, duration, success.
2.Analgesic effect : Opioid requirement, visual analogue score, rescue analgesics
3.Early ambulation and patient satisfaction feedback. 		 1day 
 
Secondary Outcome  
Outcome  TimePoints 
Sono-anatomical correlation of ankle nerves from fixed landmarks to validate the
consistency of their course and locations 		 not applicable  
 
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   Phase 4 
Date of First Enrollment (India)   28/02/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sushantbhabal05@gmail.com].

  6. For how long will this data be available start date provided 30-06-2024 and end date provided 01-07-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is randomized, single blind, parallel group, single center trial will include 60 participants who are scheduled for elective foot surgeries under ankle block, will be randomized into two groups of 30 each where Group L will receive ankle block by landmark technique and Group U will receive ankle block under ultrasound guidance both these techniques are well established practice of ankle block. The primary outcome of this study to evaluate the effectiveness of these techniques in terms of Ease of performance, duration required, block success, analgesic requirement, total duration of analgesia, patient satisfaction feedback. the secondary objective of this study is to analyze the sono-anatomical correlation of Tibial nerve, saphenous nerve, superficial and deep peroneal nerve and sural nerve by proximal tracing of the these nerves by ultrasonography from fixed landmark points.   
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