| 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
|
|
|
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
|
|
|
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 |