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CTRI Number  CTRI/2025/08/093538 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 08/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of 2 techniques of spinal anesthesia in more than 65 year with degenerative disc desease 
Scientific Title of Study   Comparison of paramedian vs paraspinous approach for subarachnoid block in elderly patients with degenerative spine disease undergoing total knee arthroplasty 
Trial Acronym  TTS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NEHA GARG 
Designation  ASSISTANT PROFESSOR 
Affiliation  AIIMS 
Address  Room no 705, National center for aging, AIIMS, Delhi

South
DELHI
110029
India 
Phone  9711896795  
Fax    
Email  neha.dr.garg@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  NEHA GARG 
Designation  ASSISTANT PROFESSOR 
Affiliation  AIIMS 
Address  Room no 705, NATIONAL CENTRE FOR AGING, AIIMS, NEW DELHI

South
DELHI
110029
India 
Phone  9711896795  
Fax    
Email  neha.dr.garg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  NEHA GARG 
Designation  ASSISTANT PROFESSOR 
Affiliation  AIIMS 
Address  Room NO 705, National Center for aging, AIIMS, New Delhi

South
DELHI
110070
India 
Phone  9711896795  
Fax    
Email  neha.dr.garg@gmail.com  
 
Source of Monetary or Material Support  
National Centre for aging, AIIMS, New Delhi, pin code 110029 
 
Primary Sponsor  
Name  Not applicable 
Address  not applicable 
Type of Sponsor  Other [NA] 
 
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 
NEHA GARG  AIIIMS, New Dlehi  5 th floor, operation theatre complex, National Centre for Aging, Ansari Nagar, Delhi- 110029
South
DELHI 
9711896795

neha.dr.garg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Paramedian approach of subarachnoid block  The spinal needle is inserted at an angle of 15-25 degree, 1-2 cm from the from the midline of spine 
Intervention  Paraspinous approach of subarachnoid block  The spinal needle is inserted at 0-5 degree angle , 1-2 cm from the midline of spinous process 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged 65 years or older.
Diagnosis of degenerative spine disease confirmed by imaging.
ASA Physical Status Classification 1-3.
Scheduled for a surgical procedure suitable for subarachnoid block.
 
 
ExclusionCriteria 
Details  Known contraindications to subarachnoid block.
Coagulopathy or anticoagulant therapy.
Severe spinal deformity beyond degenerative changes.
Known allergy to local anesthetics.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the number of attempts required for successful sub arachnoid block with paramedian and paraspinous approaches in elderly patients with degenerative spine disease.  0-10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To assess procedure time, patient comfort, & incidence of complications (PDPH, Backache) in both approaches.  day 1 & day 3 for PDPH & Bachache 
 
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   N/A 
Date of First Enrollment (India)   06/09/2025 
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="1"
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 - NO
Brief Summary  

Total Knee Arthroplasty (TKA) is a common surgical procedure performed to alleviate pain and improve functionality in patients suffering from knee osteoarthritis, particularly in the elderly population. With increasing age, patients often present with a variety of comorbid conditions, one of which is degenerative spine disease (DSD). This condition can lead to anatomical changes and challenges in achieving optimal spinal anesthesia for procedures such as TKA.

Spinal anesthesia, specifically subarachnoid block (SAB), is a widely utilized technique for TKA due to its advantages of reliable muscle relaxation, effective analgesia, and reduced systemic complications compared to general anesthesia. However, elderly patients with DSD present a unique challenge due to altered spinal anatomy, such as narrowed intervertebral spaces and osteophyte formation, which may complicate needle placement for the block. In such cases, the choice of approach for SAB becomes critical to minimize complications and ensure a successful block.

The two commonly used approaches for spinal anesthesia are the paramedian and the paraspinous techniques. While both have been described in the literature, the comparative efficacy, safety, and ease of performing these approaches in elderly patients with DSD have not been extensively studied. This study aims to evaluate and compare the paramedian and paraspinous approaches for SAB in elderly patients undergoing TKA, specifically those with degenerative spine changes 
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