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CTRI Number  CTRI/2025/09/094159 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 02/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   USG vs Palpatory method for Spinal in Infra-Umbilical Surgeries. 
Scientific Title of Study   USG Assisted Versus Surface Landmark Technique For Subarachanoid Block In Patients Undergoing Infra Umbilical 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  Renganathan Sockalingam 
Designation  Associate Professor 
Affiliation  VELAMMAL MEDICAL COLLEGE AND HOSPITAL 
Address  Room no 2 ,Clinical Division,Department of Anesthesia Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu 625009

Madurai
TAMIL NADU
625009
India 
Phone  09500025879  
Fax    
Email  renganathansockalingam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Renganathan Sockalingam 
Designation  Associate Professor 
Affiliation  VELAMMAL MEDICAL COLLEGE AND HOSPITAL 
Address  Room no 2 ,Clinical Division,Department of Anesthesia Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu 625009


TAMIL NADU
625009
India 
Phone  09500025879  
Fax    
Email  renganathansockalingam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Renganathan Sockalingam 
Designation  Associate Professor 
Affiliation  VELAMMAL MEDICAL COLLEGE AND HOSPITAL 
Address  Room no 2 ,Clinical Division,Department of Anesthesia Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu 625009
Annupanadi

TAMIL NADU
625009
India 
Phone  09500025879  
Fax    
Email  renganathansockalingam@gmail.com  
 
Source of Monetary or Material Support  
Room no 2 ,Clinical Division,Department of Anesthesia Velammal medical college and Research Institute ,Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu India 625009 
 
Primary Sponsor  
Name  Velammal Medical College 
Address  Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu 625009 
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 
C Navin  Velammal Medical college and hospital  Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu 625009 Annupanadi
Madurai
TAMIL NADU 
09500025879

navin.immortals@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VELAMMAL MEDICAL COLLEGE AND RESEARCH INSTITUTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Landmark Guided SAB in Infra Umblical Surgeries  Patient Positioning: The patient is typically placed in a sitting or lateral decubitus (on their side) position. Identifying Landmarks: The primary landmark used is the Tuffiers line, an imaginary line connecting the highest points of the iliac crests (the bony prominences on the hips). Spinal Interspace: Tuffiers line generally corresponds to the L4 vertebral body or the L4-L5 intervertebral space. The procedure is usually performed at the L3-L4 or L4-L5 interspaces, as the spinal cord typically ends at the L1-L2 level in adults, making these spaces safer for needle insertion. Needle Insertion: The anesthesiologist palpates the spinous processes of the vertebrae and inserts the spinal needle into the chosen interspace, either using a midline or paramedian approach. The correct placement is confirmed by the free flow of cerebrospinal fluid (CSF). 
Intervention  USG Assisted SAB in Infra Umblical Surgeries  Pre-procedural Scan: The anesthesiologist places a low-frequency ultrasound probe on the patients back to obtain images of the lumbar spine. Identifying Structures: They identify the spinous processes, laminae, and the posterior dura, which appears as a bright, hyperechoic line. The intervertebral spaces are located as "acoustic windows" between the bony structures. Marking the Site: Once the correct intervertebral space is identified (usually L3-L4 or L4-L5 for infra-umbilical surgeries), the anesthesiologist marks the precise midline insertion point and the optimal angle for the needle. Needle Insertion: The spinal needle is then inserted at the marked site, guided by the pre-procedural scan and the measured depth to the dura.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA class I & II posted for elective infraumbilical surgeries requiring Subarachnoid block 
 
ExclusionCriteria 
Details  -patient refusal
-Bleeding diathesis
-contraindicated for spinal anesthesia
-patient with systemic or localized infection at
puncture site.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
first pass needle success rate.   It is the time calculated in seconds from the first skin puncture with the spinal needle to free flow of CSF. 
 
Secondary Outcome  
Outcome  TimePoints 
number of needle puncture attempts.
2.time taken to establish landmarks.
3.time taken to accomplish SAB
 
1.number of times needle was taken out of the skin & redirected for free flow of csf
2.time taken to establish puncture point before needle entry either using usg or landmark in seconds
3.time taken to accomplish desired sensory & motor level 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/09/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

In USG group, ultrasound scanning in sitting position was done in preoperative room by an anesthesiologist. An ultrasound probe was placed transversely in the midline in the lumbar region to visualize the best view of the spinous process which appeared linear hypoechoeic acoustic shadow. Using M mode of USG L4-L5 and L3-L4 interlaminar space identified and marked using a surgical skin marking pen. Patient shifted to operation room and again in sitting position, 25G Quincke’s spinal needle was introduced in the marked point maintaining the same angle in which the USG probe was kept and subarachnoid space location was confirmed by backflow of clear CSF. 2-3 ml of 0.5% hyperbaric bupivacaine was given and patient made to lie down in supine position, Spinal uptake levels checked and surgery proceeded.  In the SLG group spine was palpated in the midline and two intervertebral spaces L4-L5 and L3-L4 were palpated and spinal anaesthesia is performed by conventional palpatory surface landmark technique. And 2-3 ml of 0.5% hyperbaric Bupivacaine was given .The first pass needle insertion success and number of needle puncture attempts taken to achieve spinal anaesthesia were recorded.


 
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