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CTRI Number  CTRI/2023/03/050911 [Registered on: 21/03/2023] Trial Registered Prospectively
Last Modified On: 17/03/2023
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 approaches of sciatic nerve block via ultrasound guidance 
Scientific Title of Study   Ultrasound-guided supine popliteal sciatic nerve block: Crosswise approach to popliteal sciatic (CAPS) versus Posterior approach 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varun Singla 
Designation  Assistant Professor 
Affiliation  PGIMER Chandigarh 
Address  Anesthesia Office, OT complex, 4th floor, Nehru Block, PGIMER Chandigarh. 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  8427474087  
Fax    
Email  drvarunsinglapgi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Varun Singla 
Designation  Assistant Professor 
Affiliation  PGIMER Chandigarh 
Address  Anesthesia Office, OT complex, 4th floor, Nehru Block, PGIMER Chandigarh. 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  8427474087  
Fax    
Email  drvarunsinglapgi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Varun Singla 
Designation  Assistant Professor 
Affiliation  PGIMER Chandigarh 
Address  Anesthesia Office, OT complex, 4th floor, Nehru Block, PGIMER Chandigarh. 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  8427474087  
Fax    
Email  drvarunsinglapgi@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research Sector 12 Chandigarh 
 
Primary Sponsor  
Name  PGIMER Chandigarh 
Address  Anaesthesia Office, OT complex, 4th floor, Nehru Block, PGIMER Chandigarh 160012 
Type of Sponsor  Research institution 
 
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 Varun Singla  PGIMER Chandigarh  Anaesthesia Office, OT complex, 4th floor, Nehru block, PGIMER Chandigarh 160012
Chandigarh
CHANDIGARH 
8427474087

drvarunsinglapgi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instt Ethics Committee (Intramural) PGIMER Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S82||Fracture of lower leg, including ankle, (2) ICD-10 Condition: S92||Fracture of foot and toe, except ankle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group I (PSNB Group): Patients will be given USG-guided Popliteal sciatic nerve block using 20ml of 0.5% Bupivacaine  Administration of combined sciatic and saphenous nerve block B) Sciatic nerve Block Posterior approach: The PSNB technique will be performed using a linear or curvilinear USG transducer placed in the transverse position at the popliteal crease with knee and hip of the patient flexed to allow for USG placement, and then the popliteal artery and vein will be identified. The biceps femoris muscle will be observed lateral to the popliteal artery, and the semimembranosus and semitendinosus muscles will be identified in the medial plane. The tibial nerve will be seen as a hyperechoic, rounded structure lateral to the popliteal vein. The common peroneal nerve will be visible lateral to the tibial nerve. The transducer will be advanced proximally until the tibial and peroneal nerves come together to form the sciatic nerve. A 10-cm, 22-G Stimuplex needle (B. Braun Medical Ltd., Melsungen, Germany) will be inserted below the midpoint of transducer using an out-of-plane approach. The needle tip will be placed into the space between the two components of the sciatic nerve slightly separated by adipose tissue at the point of division. 20ml of 0.5 % bupivacaine will be injected and perineural spread will be noted in real time under USG.5 Patient’s limb will be made supine just after injection of drug as leg-up position for sciatic nerve block may lead to a more proximal distribution of the local anesthetic and may result in a faster onset of sensory and motor blocks as well as longer duration of blockade.6  
Intervention  Group II (CAPS Group): Patients will be given USG-guided CAPS (Crosswise approach to popliteal sciatic) block using 20ml of 0.5% Bupivacaine  CAPS: Linear or curvilinear USG probe will be placed in the transverse plane over the lateral aspect of the thigh at or below the intermuscular groove formed by vastus medialis and biceps femoris muscle. The limb position will be facilitated by placing a folded towel or foam leg elevator underneath the calf muscles to help in probe placement. The probe will be moved in cephalad direction from the lateral aspect of popliteal fossa to identify the hyperechoic sciatic nerve between the hypoechoic biceps femoris, semitendonsus and semimembranosus. A 10-cm, 22-G Stimuplex needle (B. Braun Medical Ltd., Melsungen, Germany) will be inserted perpendicular to the skin using an out-of-plane approach in lateral to medial direction. The needle tip will be placed into the space between the two components of the sciatic nerve. 20 ml of 0.5% bupivacaine will be injected and perineural spread will be noted.2  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients between age group 18-80 years undergoing below knee surgeries, ASA physical status I-III
 
 
ExclusionCriteria 
Details  Patient refusal for nerve blocks, Allergy to amide local anaesthetic drugs, Chronic opioid therapy (>60 mg morphine daily or equivalent), Patients with thrombocytopenia/coagulopathy, on anti-coagulant and thrombolytic therapy, Morbid obesity (BMI>35 with obesity symptoms or BMI > 40), Neurological diseases, Local or systemic infection, Patients with psychiatric illness
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to perform the block   (time interval from the contact of USG probe with the patient to the end of local anaesthetic injection) 
 
Secondary Outcome  
Outcome  TimePoints 
1. Block onset time   time interval from the end of local anaesthetic injection to the achievement of complete sensory blockade of both saphenous and sciatic nerve 
2. Number of needle passes  During performance of procedure 
3. Level of procedure related pain   During performance of procedure 
4. Sciatic nerve visibility score and depth from skin  During performance of procedure 
5. Visual analog scale (VAS) scores   immediate post-operation (T1), at 2 hours (T2), 4 hours (T3), 8 hours (T4), 12 hours (T5), 16 hours (T6), 24 hours (T7), and 48 hours (T8)  
6. Time to first rescue analgesia   during 48 hr follow up 
7. 48 hour rescue analgesic consumption   during 48 hr follow up 
8. Occurrence of any adverse events/complications   during 48 hr follow up 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 3 
Date of First Enrollment (India)   01/04/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Popliteal sciatic nerve block (PSNB) is commonly practised regional anaesthesia and analgesia technique for below-knee surgeries. It is used alone or combined with a femoral or saphenous nerve block. The block can be performed blindly, guided by a nerve stimulator or ultrasound. The blind landmark-based technique is not preferred due to lower efficacy and higher complication rates.1 The use of ultrasound (USG) allows a real-time visualisation and delivery of the medication at the target site, improving precision, accuracy and safety. The nerve block can be performed in the posterior, lateral and supine positions. Lateral and prone may pose challenges in morbidly obese, pregnant, hemodynamically unstable and/or spinal injury patients.2 In supine position, the popliteal sciatic block can be performed by the posterior approach with out-of-plane needle entry, lateral or medial approach with lateral or medial in-plane needle entry respectively. The supine posterior out-of-plane approach provides the advantage of patient comfort, less chance of puncturing the popliteal vessels and shorter needle path.3, 4

Recently, Mistry et al have described an USG-guided CAPS (Crosswise approach to popliteal sciatic) block in a case series of 5 patients successfully with the advantage of better patient comfort as there is no need of patient positioning, flexion of hip and knees and external assistance.2

We aim to compare the USG-guided posterior approach of popliteal sciatic block and CAPS block. 

 
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