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CTRI Number  CTRI/2022/10/046853 [Registered on: 27/10/2022] Trial Registered Prospectively
Last Modified On: 06/08/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Comparative 
Study Design  Other 
Public Title of Study   Comparison of landmark-guided versus ultrasound assisted spinal anaesthesia for lower limb surgeries 
Scientific Title of Study   Comparative evaluation of landmark-guided versus preprocedural ultrasound assisted paramedian technique in subarachnoid block for lower limb surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Surekha Chavan 
Designation  Associate Professor 
Affiliation  B.J. Medical College and sassoon general hospitals, Pune 
Address  Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001

Pune
MAHARASHTRA
411001
India 
Phone    
Fax    
Email  surekhachavan659@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  B.J. Medical College and sassoon general hospitals, Pune 
Address  Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001

Pune
MAHARASHTRA
411001
India 
Phone  09022177719  
Fax    
Email  bjsujit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  B.J. Medical College and sassoon general hospitals, Pune 
Address  Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001

Pune
MAHARASHTRA
411001
India 
Phone  09022177719  
Fax    
Email  bjsujit@gmail.com  
 
Source of Monetary or Material Support  
B.J.G.M.C and S.G.H Pune, Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001  
 
Primary Sponsor  
Name  Dr Sujit Kshirsagar 
Address  Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001 
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 Sujit Kshirsagar  Sassoon General Hospital   Trauma operation theatre, trauma care centre, Ground floor, B. J. Govt. MEDICAL COLLEGE and SASSOON GENERAL HOSPITALS, PUNE
Pune
MAHARASHTRA 		 09022177719

bjsujit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, B. J. Govt. MEDICAL COLLEGE, SASSOON GENERAL HOSPITALS, 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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age 18 to 80yrs
2• height 145–180 cm
3• weight 50–100 kg
4• Both genders- male and female
5• ASA grade I and ASA grade II
6• Undergoing elective orthopaedic surgery of
maximum 2 hrs of duration under spinal anaesthesia 
 
ExclusionCriteria 
Details  1• Age <18 yrs, > 80 yrs
2• Height<145cm, > 180 cm
3• Weight <50kgs, > 100 kg
4• ASA grade III and ASA grade IV
5• Patients with hepatic, cardiac, pulmonary, neuropsychiatric, renal or thyroid disease
6• Hypersensitivity to Bupivacaine
7• Any contraindication to spinal anaesthesia ( local infection, spinal deformity, coagulopathy)  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
. total number of spinal needle redirections
2.The number of spinal needle attempts for a successful Subarachnoid block
3.successful Subarachnoid block rate in first attempt 		 every 3 min in first 30 min followed by repeat measurements every 5 min till the end of surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
1.time taken to perform successful Subarachnoid block
2.patients’ satisfaction for the technique.
 		 every 3 min in first 30 min followed by repeat measurements every 5 min till the end of surgery. 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/10/2022 
Date of Study Completion (India) 06/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Subarachnoid block can be administered via two techniques;. Landmark guided  and USG guided. The current literature encourages the use of point-of-care ultrasound (POCUS) as adjunct to subarachnoid block (SAB) as it facilitates accurate needle placement, thereby reducing the number of needle redirections. Studies have shown that preprocedural USG’assisted neuraxial blocks reduces the number of attempts required for successful block.[1,2].[3]  Traditional spinal anaesthesia relied on the palpation of surface landmarks to identify the intervertebral levels; however, the possible occurrence of spine degeneration, supraspinous and interspinous ligament calcification, narrowing of intervertebral space, lumbar scoliosis, and deformities may make the identification of the intervertebral space unreliable and cause difficulties in needle insertion. 
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