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CTRI Number  CTRI/2024/01/061177 [Registered on: 08/01/2024] Trial Registered Prospectively
Last Modified On: 03/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Comparative 
Study Design  Other 
Public Title of Study   To study better method to give sciatic nerve block between ultrasound guidance alone vs ultrasound with nerve stimulator guidance 
Scientific Title of Study   A Randomized Comparison Between ultrasound guided Vs ultrasound with PNS guided Sciatico-Femoral Nerve Block for Lower Limb 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  Unmekha Pardhi 
Designation  Junior Resident 
Affiliation  BJGMC and SGH, Pune 
Address  Dept of Anesthesiology, BJGMC and SGH, Pune

Pune
MAHARASHTRA
411001
India 
Phone    
Fax    
Email  unmekhapardhi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  BJGMC and SGH, Pune 
Address  Trauma ICU, Department of trauma care centre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road, Pune-411001

Pune
MAHARASHTRA
411001
India 
Phone  08983741147  
Fax    
Email  bjsujit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  BJGMC and SGH, Pune 
Address  Trauma ICU, Department of Trauma Care Centre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road, Pune-411001


MAHARASHTRA
411001
India 
Phone  08983741147  
Fax    
Email  bjsujit@gmail.com  
 
Source of Monetary or Material Support  
Sassoon General Hospital, Pune 
 
Primary Sponsor  
Name  Unmekha Pardhi 
Address  Dept of Anesthesiology, BJGMC and SGH, Pune 
Type of Sponsor  Other [Self] 
 
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 Unmekha Pardhi  Sassoon General Hospital, Pune  Trauma Operation theatre, Ground Floor, Behind Casualty, Sassoon General Hospital, Station Road, Pune-411001
Pune
MAHARASHTRA 		 8983741147

unmekhapardhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, B.J. Govt. Medical College, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S829||Unspecified fracture of lower leg,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. American Society of Anaesthesiologists physical status I-II
2. Patients schedule for below knee surgery
3. Ultrasound visibility score equal or greater than 10
 
 
ExclusionCriteria 
Details  1. ASA III and IV
2. Pregnant PAtients
3. Patients with coagulation disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The aim of the study is to compare quality of anaesthesia in both the
groups. Primary objective is to compare the onset time of sensory and motor blockade of
Sciatico-femoral block by USG alone vs USG with PNS guidance. 		 Baseline, 15 min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min. 
 
Secondary Outcome  
Outcome  TimePoints 
2) To compare Performance time of block (Performance time of block is the preparing time and procedure time. Preparing time defined as the time from the beginning of the sterile preparation right before the first needle contact with the skin. Procedure time is time between the insertion of the needle and the end of local anaesthetic injection)
3) To compare duration of post op analgesia. (time to first rescue analgesic)
4) To compare any side effects and complications if any in both the groups.
 		 Baseline
Before SF block
5 min after SF block
15 min after SF block
30 min after SF block
1 hr after SF block
1 hr 30min after SF block
2 hr after SF block
2 hr 30 after SF block
3 hr after SF block
3 hr 30 min after SF block
4 hr after SF block
 
 
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)   13/01/2024 
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 Yet Recruiting 
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  
Over the past ten years, ultrasound guiding has grown in popularity and
has made it possible to do numerous peripheral nerve blocks that were previously impractical to carry out
using conventional methods. Many different forms of peripheral nerve blocks have been performed on
both adults and children in recent years using ultrasound technology [1–9]. Direct visualization of nerve
structures, real-time needle guidance to the target, and tracking of local anesthetic diffusion are all made
possible by ultrasound imaging. [10] According to certain reviews and meta-analyses, ultrasound-guided
peripheral nerve blocks may have a number of advantages, such as a higher success rate, a quicker
commencement of blocks, and perhaps better quality sensory blocks [11–16]. Sciatic nerve blocks are
frequently used in clinical practice to provide anesthesia and analgesia during lower limb surgery. Nerve
stimulation guidance is a traditional technique for sciatic nerve block [17,18] popular regional anesthesia
(RA) procedure for delivering anaesthetic or analgesia for below knee surgery is the sciatic nerve either
by itself or in conjunction with a femoral or saphenous nerve block, it is employed. We proposed that
using ultrasonography combined with PNS guidance to block both sciatic nerve branches would achieve
good quality of anaesthesia and will shorten the duration of the sciaticofemoral nerve block. The goal of
the current study was to compare the use of combined ultrasound and pr(PNS) guidance with the
ultrasound guidance alone.
9. MATERIALS AND METHODS: - 80 consenting patients fulfilling the inclusion criteria will
be considered for study. Workup will be done for all patients which included a detailed History, General
physical and systemic examination and all basic investigations will be done. Patients undergoing lower
limb surgery as per the routine procedure and requirement will undergo sciatico femoral block with either
ultrasonography or ultrasonography and peripheral nerve stimulator. GROUP U: - Will be the one who
would have received Ultrasonography guided sciatico-femoral nerve block with drug Inj. Lignocaine2%
with Adrenaline + Inj. Bupivacaine 0.5% + Inj. Dexamethasone 8 mg (total volume 40 cc) and GROUP
UP: - Will be given combined Ultrasonography and PNS guided sciatico-femoral nerve block with drug
Inj. Lignocaine2% with Adrenaline + Inj. Bupivacaine 0.5% + Inj.Dexamethasone 8 mg (total volume 40
cc). Hemodynamic monitoring will be done. All patients will be meticulously monitored intraoperatively
for -A) Haemodynamic parameters {HR ,SBP,DBP,MAP,SPO2}B) Sensory Blockage will be assessed
by pin prick test using 3-point scale C) Motor grade using modified bromage scale.
 
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