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CTRI Number  CTRI/2025/11/096866 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ultrasound guided comparison of two different approaches of Sciatic nerve block in below knee surgeries 
Scientific Title of Study   USG GUIDED PARA SACRAL ISCHIAL PLANE BLOCK VS POPLITEAL SCIATIC BLOCK IN IPSILATERAL BELOW KNEE SURGERIES : PROSPECTIVE RANDOMISED CONTROL 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 Akshay Parmar 
Designation  2nd year resident 
Affiliation  SSG hospital , Vadodara / Goverment medical college , Vadodara 
Address  2nd floor , Department of anaesthesia , government medical college and SSG hospital , New surgical block building

Vadodara
GUJARAT
390001
India 
Phone  9328086963  
Fax    
Email  akshayparmar890@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Apeksha Patwa 
Designation  Associate professor 
Affiliation  Government Medical College -Baroda 
Address  2nd floor , Department of anaesthesia , government medical college and SSG hospital , New surgical block building

Vadodara
GUJARAT
390001
India 
Phone  9879540828  
Fax    
Email  patwaapeksha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Apeksha Patwa 
Designation  Associate professor 
Affiliation  Government Medical College -Baroda 
Address  2nd floor , Department of anaesthesia , government medical college and SSG hospital , New surgical block building

Vadodara
GUJARAT
390001
India 
Phone  9879540828  
Fax    
Email  patwaapeksha@gmail.com  
 
Source of Monetary or Material Support  
2nd floor , Department of anaesthesia , government medical college and SSG hospital , New surgical block building Vadodara 390001, Gujarat , INDIA 
 
Primary Sponsor  
Name  Medical college and SSG hospital , Vadodara 
Address  SSG hospital , nr Raopura road , pincode : 390001 vadoadara 
Type of Sponsor  Government 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 
DrAkshay Parmar  SSG Hospital Vadodara  1st floor, trauma operation theatre ,SSG hospital vadodara,390001 , Gujarat
Vadodara
GUJARAT 		 9328086963

akshayparmar890@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Biomedical and health Research , Government medical college ,Vadodara  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S823||Fracture of lower end of tibia, (2) ICD-10 Condition: S823||Fracture of lower end of tibia, (3) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ultrasound guided parasacral ischial plane block  The patient is positioned in Sim’s position with the lower limb to be blocked will be placed in the nondependent position. A curvilinear ultrasound (US) probe of 2-5 megahertz frequency will be placed medial to the midpoint of line joining the posterior superior iliac spine (PSIS) and greater trochanter in supero lateral direction . Then the probe will be moved in the infero- medial direction , Posteromedial border of the ischium with the pyriformis muscle overlying it will be identified at the level of the greater sciatic foramen . A 100 to 150 mm, 22-gauge insulating needle will be inserted in an in-plane approach from lateral to medial direction, targeting the posteromedial border of the ischium.The motor response of the sciatic plexus is usually obtained at a depth between 6 and 8 cm. Initially,current intensity is kept 1.5 mA.The goal is to achieve visible or palpable twitches of the hamstrings, calf muscles, foot, or toes at the current intensity of 0.3–0.5 mA. The distal motor response may be either a tibial or a peroneal response—it is not necessary to stimulate both components. Twitches of the hamstrings are equally acceptable because this approach blocks the sciatic nerve proximal to the separation of the neuronal branches to the hamstring muscles. Twenty five ml of drug will be injected after the contact of needle tip with the bone. Local anaesthetic spread under the piriformis toward the sacral plexus will be looked for.This intervention takes around 20 minutes  
Comparator Agent  Ultrasound guided popliteal sciatic block  Patient is lied down in supine position with one pillow between both knees and below heel with 30 to 45 degrees of flexion at knee joint. Linear ultrasound probe with 2 – 5 MHz frequency and around 3 – 4 cm depth is kept at popliteal crease. Then probe is moved in cephalic direction around 5 to 12 cm proximal to popliteal crease where sciatic nerve bifurcation in common paroneal and tibial nerve within paraneural sheath is identified along with part of distal femur , popliteal artery , popliteal vein are kept in vision in usg image.either side of popliteal artery lies biceps femoris muscle laterally and semitendinous and semimembranous muscles medially. Peripheral nerve stimulator with current intensity of 1.5 mA is attached with 100 mm 22 gauze insulating needle. after antiseptic precautions , Needle is inserted with in plane approach between the tendons of vastus lateralis and biceps femoris in lateral to medial direction and advanced till it reaches paraneural sheath (vloka’s sheath ). Motor response is elicited in form of dorsiflexion and eversion (CPN component)or plantar flexion and inversion (TN component).. current intensity is decreased till 0.5 mA and response in foot or great toe is observed , after negativeaspiration for blood . Drug is injected in sheath between both the components of sciatic nerve and as drug spreads , both the components getting distant can be seen in USG .here hands are kept as immobile as possible to prevent drug injection outside of paraneural sheath.This whole procedure takes around 15 to 20 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  - Patients posted for ipsilateral below knee surgeries
- Weight 45 to 75 kg
- ASA II/III/IV
- Duration of surgery less than 3 hours
- Patients able to give written and informed consent 
 
ExclusionCriteria 
Details  - Patients not willing for procedure or unable to give consent
- Patients with coagulopathy, local infection, pre- existing neuropathy.
- Patients allergic to local anaesthetics
- Patients with significant h/o drug or alcohol
abuse, psychiatric illness.
- Bilateral lower limb surgeries
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
comparison of success rate between two different approaches of sciatic nerve block [parasacral ischial plane approach and popliteal sciatic approach]  30min 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of onset, Time to achieve complete effect, Total duration of effect of sensory & motor block with duration of analgesia & hemodynamic parameters like pulse, mean arterial pressure, SpO2 with perioperative complications  30 mins 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   27/11/2025 
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 aim of study is compare efficacy between Parasacral ischial plane approach and popliteal sciatic approach for sciatic nerve block combining with femoral nerve block in ipsilateral below knee surgeries.


The patients will be randomly allocated into two groups by computer generated randomised software in opaque sealed envelope method in 1:1 ratio to undergo USG guided sciatic nerve block of either approach.


GROUP PIP : Patients will be given sciatic nerve block via parasacral ischial plane approach along with femoral nerve block under USG guidance.

GROUP PSB : Patients will be given sciatic nerve block via popliteal sciatic approach along with femoral nerve block under USG guidance .

Peripheral nerve stimulator will be used as aid for confirmation of needle tip placement near nerve component.


•Comparison of success rate between two different approaches of sciatic nerve block  as primary outcome.


•As a secondary outcome Duration of onset, time to achieve complete effect, Total duration of effect of sensory and motor block with duration  of  analgesia, Haemodynamic parameters like pulse, mean arterial pressure, SpO2, Peri-operative complications.


The proposed clinical research will compare two different techniques; those are parasacral ischial plane and popliteal sciatic approaches comparing sciatic nerve block characteristics for better efficacy,assessment of sensory and motor block, intra operative haemodynamic, post operative analgesia.

 

 
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