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CTRI Number  CTRI/2025/09/094246 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
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 Modified Paramedian vs. Midline Approach for Spinal Anesthesia: Success Rates on First Attempt in Surgical Patients” 
Scientific Title of Study   Comparison of pre-procedural ultrasound assisted modified paramedian technique versus ultrasound assisted midline technique on successful dural puncture on first attempt in patients undergoing surgeries under spinal anesthesia - A Randomized Controlled Trial. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
RC/2025/26 version 1, may 8 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bannur Manisha 
Designation  MD Anaesthesiology 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Pondicherry Institute of Medical Sciences,Anaesthesia department,extension bulding 4th floor

Pondicherry
PONDICHERRY
605014
India 
Phone  7207407329  
Fax    
Email  manishabnr471@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arish BT 
Designation  Professor  
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Pondicherry Institute of Medical Sciences kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014

Pondicherry
PONDICHERRY
605014
India 
Phone  9791853400  
Fax    
Email  ajstyle.bt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bannur Manisha 
Designation  MD Anaesthesiology 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Pondicherry Institute of Medical Sciences, Anaesthesia department,extension bulding,4th floor kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014

Pondicherry
PONDICHERRY
605014
India 
Phone  7207407329  
Fax    
Email  manishabnr471@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute of Medical Sciences 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Sciences 
Address  Pondicherry Institute of Medical Sciences Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014 
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 
Bannur Manisha  Pondicherry institute of medical sciences   Pondicherry institute of medical sciences Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014
Pondicherry
PONDICHERRY 		 7207407329

manishabnr471@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS Institute Ethics Commitee  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  Pre procedural ultrasound assisted midline Technique  Pre procedural ultrasound assisted midline Technique In patients undergoing surgeries under spinal anaesthesia 
Intervention  Pre procedural ultrasound assisted modified paramedian Technique  Pre procedural ultrasound assisted modified paramedian Technique in patients undergoing surgeries under spinal anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients belonging to American society of Anesthesiologist physical status classification (ASA- PS -I, II & III)
2. Patients scheduled for elective surgeries under spinal anesthesia 
 
ExclusionCriteria 
Details  . 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary objective: To compare the rate of successful dural puncture on the first needle insertion attempt between pre procedural ultrasound assisted modified paramedian technique and pre procedural ultrasound assisted midline techniques in patients undergoing surgeries under spinal anesthesia.  out come would be assessed immediately after the procedure 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the following parameters between the two groups:
1. Number of needle insertion attempts
2. Number of needle passes
3. Visibility of ligamentum flavum/ duramater complex (LFD and anterior complex.
4. Distance from skin to ligamentum flavum/ duramater complex (LFD) and to intrathecal space (ITS)
5. Complications 		 20min 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   14/09/2025 
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="2"
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  

This is a randomized controlled trial done at Pondicherry Institute of Medical Sciences which will compare pre-procedural ultrasound-assisted midline and modified paramedian techniques (0.5 cm & 1 cm lateral) for spinal anesthesia in 108 adult surgical patients. Primary outcome is first-attempt dural puncture success; secondary outcomes include number of passes, LFD visibility, anatomical distances, and complications. The study hypothesizes that modified paramedian approaches will yield higher first-attempt success rates, fewer needle manipulations, and reduced patient discomfort compared to the midline technique.

 
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