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CTRI Number  CTRI/2024/04/066076 [Registered on: 22/04/2024] Trial Registered Prospectively
Last Modified On: 20/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   In high-risk patients with significant cardiovascular and other systemic disorders Peripheral nerve blocks like PIP and Lateral approach for proximal sciatic nerve block provide sufficient block of pain pathways at different levels providing excellent anaesthesia at the site of surgery 
Scientific Title of Study   A Randomized Comparative study on Ultrasound guided Parasacral Ischial plane block versus Lateral approach of Proximal Sciatic Nerve block in patients undergoing below knee 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 Prashant Kumar 
Designation  Junior resident (MD ANAESTHESIA) 
Affiliation  TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER 
Address  DEPARTMENT OF ANAESTHESIA, TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER, MORADABAD
DEPARTMENT OF ANAESTHESIA, TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER, MORADABAD
Moradabad
UTTAR PRADESH
244001
India 
Phone  8587842226  
Fax    
Email  prashant.pandey029@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MUKESH KUMAR PRASAD 
Designation  PROFESSOR and HOD 
Affiliation  Teerthanker Mahaveer Medical College and Research Center Moradabad  
Address  DEPARTMENT OF ANAESTHESIA, TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER, MORADABAD
DEPARTMENT OF ANAESTHESIA, TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER, MORADABAD
Moradabad
UTTAR PRADESH
244001
India 
Phone  9837624543  
Fax    
Email  mukeshkumar2002@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PRASHANT KUMAR 
Designation  Junior Resident (MD ANAESTHESIA) 
Affiliation  TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER 
Address  DEPARTMENT OF ANAESTHESIA, TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER, MORADABAD
DEPARTMENT OF ANAESTHESIA, TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER, MORADABAD
Moradabad
UTTAR PRADESH
244001
India 
Phone  8587842226  
Fax    
Email  prashant.pandey029@gmail.com  
 
Source of Monetary or Material Support  
TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER. MORADABAD UTTAR PRADESH 
 
Primary Sponsor  
Name  TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER 
Address  TEERTHANKER MAHAVEER MEDICAL COLLEGE AND RESEARCH CENTER, MORADABAD, UTTAR PRADESH, 244001 
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 PRASHANT KUMAR  Dr Prashant Kumar  TEERTHANKER MEDICAL COLLEGE MORADABAD UTTAR PRADESH
Moradabad
UTTAR PRADESH 		 8587842226

prashant.pandey029@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE T.M UNIVERSITY MORADABAD UTTAR PRADESH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lateral approach for proximal sciatic nerve block 20ml 0.5% ropivacaine and Adductor canal block 10ml 0.5% ropivacaine   A Randomized Comparative study on Ultrasound guided Parasacral Ischial plane block versus Lateral approach of Proximal Sciatic Nerve block in patients undergoing below knee surgeries 
Comparator Agent  PIP 20ml point five percent ropivacaine and Adductor canal block 10ml point five percent ropivacaine  A Randomized Comparative study on Ultrasound guided Parasacral Ischial plane block versus Lateral approach of Proximal Sciatic Nerve block in patients undergoing below knee surgeries 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of age group 18-70 years Under American Society of Anaesthesiologists physivcal status II to IV, scheduled for lower limb surgeries, Informed and Written consent. 
 
ExclusionCriteria 
Details  Infection at site of injection, Allergy to Local Anaesthetics, Duration of the surgery morethan 3 hours. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare Sensory and motor block characteristic (onset & duration) in both the groups.
 		 Duration of motor block will be bromage – 1.(0 min,15min,30min,45min,60min, 2hrs 4hrs, 8hrs,12 hrs, 16hrs,18hrs, and 24hrs.)
Duration of sensory block will be regain of pin prick.(0 min, 15min, 30min, 45min, 60min, 2hrs 4hrs, 8hrs,12 hrs, 16hrs,18hrs, and 24hrs.)
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare VAS score, time for first rescue analgesia, block performance time, total analgesic consumption in 24hrs,haemodynamic parameters, number of patients requiring rescue analgesia, complications in both the groups.  To compare VAS score in both the groups.
To compare block performance time in both groups. [1]
To compare time for first rescue analgesia in both the groups.[1]
To compare the total analgesic consumption in 24hrs in both the groups .
To compare haemodynamic parameters in both the groups.
To compare number of patients requiring rescue analgesia in both the groups.[1]
To compare the complications in both the groups.
 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/04/2024 
Date of Study Completion (India) 08/05/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

After getting approval from College research committee (CRC)  and Institutional Ethical Committee (IEC), Patients fulfilling inclusion criteria will be included in our study.

This prospective randomized study will be carried out in the Department of Anaesthesiology  at Teerthanker  Mahaveer Medical College and Research Centre.

Pre- anesthetic evaluation will be done prior to surgery.

Written informed consent for the procedure and anaesthesia will be taken from all the patients and participation-information sheet will be filled out.

Each patient will be explained the entire procedure, use of Visual Analogue Scale (VAS) and possible complications.(bleeding, hematoma, bradycardia, tachycardia, hypertension, hypotension, peripheral nerve injury or systemic toxicity to local anaesthetic drug.).

Two groups will be created

Group P (n=40)- PIP (20ml 0.5% ropivacaine)[2]+ Adductor canal block (10ml 0.5% ropivacaine)[3] 

Group S (n=40)- Lateral approach for proximal sciatic nerve block(20ml 0.5% ropivacaine) +Adductor canal block.(10ml 0.5% ropivacaine each

Duration of motor block will be bromage – 1.

(0 min,15min,30min,45min,60min, 2hrs 4hrs, 8hrs,12 hrs,

 16hrs,18hrs,

 and 24hrs.)

Duration of sensory block will be regain of pin prick.

(0 min, 15min, 30min, 45min, 60min, 2hrs 4hrs, 8hrs,12 hrs,

 16hrs,18hrs, and 24hrs.)

Post Op the patient will be shifted to PACU and1 gm PCM 8 hrly i/v

 will be given as per standard institute protocol. Post OP vitals will be

 monitored at 0 min, 15min,30min,45min,60min, 2hrs 4hrs, 8hrs,12 hrs,

 16hrs,18hrs, and 24hrs


Pain will be evaluated using visual analogue scale (VAS) that


 characterizes and measure pain between 0-10. (0


 min,15min,30min,45min,60min, 2hrs 4hrs, 8hrs,12 hrs, 16hrs,18hrs,


 and 24hrs.).

Number of patients requiring rescue analgesia will be noted. 


Time of first rescue analgesia(I/V tramadol 1.5mg/kg) VAS  >4 .


Total rescue analgesic consumption in milligrams over 24 hrs.


The patients will be observed for first 24 hours for bleeding,

hematoma,bradycardia,tachycardia,hypertension,hypotension

, peripheral nerve injury or systemic toxicity to local anaesthetic drug


Data will be analyzed using the appropriate statistical method

 
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