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CTRI Number  CTRI/2024/08/072493 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 12/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal 
Study Design  Other 
Public Title of Study   A study to compare Lumbar paramedian versus Taylor approach in spinal anesthesia in Indian elderly population 
Scientific Title of Study   Comparative Study of Lumbar Paramedian versus Taylor Approach at Spinal Anesthesia among Indian Elderly Population 
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 Mandira Mavinakere Giridhar 
Designation  Junior Resident  
Affiliation  Kasturba Medical College and Hospital 
Address  Department of Anaesthesiology Kasturba Medical College and Hospital Madhav nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9930966706  
Fax    
Email  mandy.mg1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Kumar HD 
Designation  Additional Professor and Guide  
Affiliation  Kasturba Medical College and Hospital 
Address  Department of Anaesthesiology Kasturba Medical College and Hospital Madhav nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9008415858  
Fax    
Email  arunhd2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arun Kumar HD 
Designation  Additional Professor and Guide  
Affiliation  Kasturba Medical College and Hospital 
Address  Department of Anaesthesiology Kasturba Medical College and Hospital Madhav nagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9008415858  
Fax    
Email  arunhd2000@yahoo.com  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital, Madhav nagar Manipal- 576104,Karnataka, India  
 
Primary Sponsor  
Name  Dr Mandira Mavinakere Giridhar 
Address  Department of Anaesthesiology Kasturba Medical College and Hospital, Madhav nagar Manipal- 576104, Karnataka, India Madhav nagar Manipal 
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 Mandira Mavinakere Giridhar   Kasturba Hospital, Manipal  Department of Anaesthesiology Madhav nagar Manipal- 576104
Udupi
KARNATAKA 
9930966706

mandy.mg1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2  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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists Physical Status II and III 
 
ExclusionCriteria 
Details  Patient refusal
Infection at the site of injection
Allergy
Uncorrected Hypovolemia
Increased Intracranial Pressure
Coagulopathy
Sepsis
Patients in altered mental status
Fixed cardiac output states
Indeterminate neurological disease
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Assess blood in CSF
Assess aspiration of CSF while injecting drug  
2 years  
 
Secondary Outcome  
Outcome  TimePoints 
Number of needle passes
Level of spinal anesthesia achieved
immediate adverse effects postoperatively  
2 years  
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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   N/A 
Date of First Enrollment (India)   20/08/2024 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mandy.mg1@gmail.com].

  6. For how long will this data be available start date provided 15-04-2026 and end date provided 22-07-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

An observational, single blinded study will be done in patients undergoing spinal anesthesia for elective  lower abdominal surgery.

The approach for spinal anesthesia is decided by the consultant anaesthesiologist according to the patient’s condition, convenience of performing the procedure and experience of the consultant in performing the procedure. It is a routine procedure to select either one of the approaches by the anaesthesiologist.

Procedure- After shifting patient to the operating room, electrocardiographic (ECG) monitoring of leads II and V5, noninvasive blood pressure (NIBP) and pulse oximetry will be established and the baseline vitals will be recorded. Intravenous access will be secured in the non dominant hand and an infusion of Ringer Lactate will be started. Local anesthesia 2ml of 2% Lignocaine will be administered Patients will be administered subarachnoid block using either by paramedian in L3-L4 interspace (or one interspace above or below if this space is not well felt) or Taylor’s approach ( L5-S1 interspace) using 23 SWG Quinke Babcock needle. The drug will be administered according to the patient. The number of attempts taken, presence of adequate CSF flow, blood tinged CSF, technique of delivering local anesthetic, technique of delivering drug will be noted. The drug will be injected intrathecally over a period of 10 seconds once free flow of clear cerebrospinal fluid is obtained.

A cold alcohol swab will be used to check appreciation of temperature. Check with the cold swab will be performed every 2 minutes along the midclavicular line on both sides. The higher of the two sides will be taken as end point for this parameter. Onset of analgesia at T10 will be noted. The sensory level will be checked every 2 minutes as described above until the level does not ascend any further for 4 consecutive readings. This dermatomal level will be noted as the highest level of analgesia. Sensory level will be checked every 5 minutes thereafter till the end of 1 hour, and every 15 minutes thereafter till 2-segment regression (defined as recovery of sensory block by 2 segments from the highest level achieved in that patient) and sensory recovery (around S2- S4 segments) occur

Motor blockade will be assessed by modified Bromage scale (0-1-2-3) at similar intervals as assessment of sensory block. (0 = no paralysis, able to flex hip/knee/ankle; 1 = able to flex knee 

and ankle, unable to raise extended leg; 2 = able to flex ankle, unable to flex hip and knee; 3 = unable to flex hip, knee and ankle). Motor blockade will be evaluated at 2-minute intervals till a modified Bromage score of 3 is obtained or till maximum motor blockade is achieved. This time is noted as onset of motor blockade. The time at which ankle movement returns is noted to indicate recovery from motor blockade.

Success was defined as obtaining CSF in one attempt. After removing stylet, if there is presence of blood with CSF this is considered as unsuccessful attempt. Aspiration of CSF is done after CSF flow is noted and during injecting of drug in beginning, middle and end phases on aspiration CSF flow is seen is considered as successful.

The number of needle passes was defined as the number of fresh attempts done to obtain a successful subarachnoid tap. Number of needle redirections was defined as the change in the direction of the needle to obtain a successful subarachnoid tap. Duration of procedure was defined as the time from needle insertion to withdrawal. An attempt was considered unsuccessful if the operator removed the stylet and saw no CSF. Failure was considered when no CSF was obtained after 2 attempts. In case of failure in paramedian approach then patients will be given general anaesthesia. If Taylor’s approach fails then general anesthesia was given.

 Immediate adverse effects postoperatively- Urinary retention

 Risks: There is minor risk over minimal risk. The risks mentioned are associated with the routine procedure. No additional risks present.

1) Presence of spinal deformities, anatomical defects.

2) Elderly population is vulnerable to having varying hemodynamic levels, multiple comorbidities which will need careful monitoring of the patient.

3) Presence of different patient responses intraoperatively and their management

A) Hypotension (MAP< 60mmHg)- Increased rate of fluid administeration and or bolus dose of IV Mephentermine 3mg 

B) Bradycardia ( HR<50 bpm)- Bolus dose of IV Atropine 0.6mg 

C) Desaturation (SpO2 < 94%) - Supplemental oxygen ( 3-5L via Hudson mask)


 

Benefits: 

    1) Optimize patient needs.


2)  Provide better understanding in order to use which technique on elderly patients.

3)  Determine which method is resource efficient according to practitioner expertise, cost effectiveness and hospital resources.


 
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