| CTRI Number |
CTRI/2025/10/096567 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound assisted spinal anesthesia in elderly patients |
|
Scientific Title of Study
|
COMPARISON BETWEEN MIDLINE AND PARAMEDIAN APPROACH FOR ULTRASOUND ASSISSTED SPINAL ANESTHESIA IN ELDERLY PATIENTS
-A RANDOMISED CONTROLLED STUDY |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
yenduri ananya |
| Designation |
junior resident |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of anesthesiology and critical care b block 4th floor aiims raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9246628899 |
| Fax |
|
| Email |
yenduriananya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mamta sinha |
| Designation |
Additional professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of anesthesiology and critical care aiims raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9818113061 |
| Fax |
|
| Email |
drmamta12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.mamta sinha |
| Designation |
Additional professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of anesthesiology and critical care aiims raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9818113061 |
| Fax |
|
| Email |
drmamta12@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
aiims raipur |
| Address |
GE ROAD TATIBANDH RAIPUR CHHATTISGARH INDIA 492099 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| yenduri ananya |
aiims raipur |
Department of anesthesiology and critical care
Raipur
CHHATTISGARH |
9246628899
yenduriananya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee aiims raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
midline approach |
After applying inclusion and exclusion criteria patients are grouped into paramedian approach or midline approach using randomisation technique
For Patients in midline approach group midline of spine is identified in the transverse midline view using ultrasonography and interspinous spaces are marked.
The interspinous space where the anterior and posterior complex are clearly visualised is chosen for the procedure.
the angulation used while marking the space for appropriate view should be remembered to guide the needle while performing the procedure
|
| Comparator Agent |
paramedian approach |
After applying inclusion and exclusion criteria patients are grouped into paramedian approach or midline approach using randomisation technique
For Patients in paramedian approach group midline of spine is identified in the transverse midline view using ultrasonography and spaces are marked.
corresponding interlaminar spaces are traced from the sacrum above in the parasagittal oblique view and marked.
The interlaminar space where the anterior and posterior complex are clearly visualised is chosen for the procedure.
the angulation used while marking the space for appropriate view should be remembered to guide the needle while performing the procedure
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 60 years undergoing elective lower abdominal, perineal and lower extremity surgeries under spinal anesthesia
ASA physical status 1 2 and 3 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Any contraindication of spinal anesthesia like
Coagulopathy
Hypovolemia
Local infection
Raised intracranial pressure
Unknown neurological disorder
Previous history of lumbar spine surgery
Anatomical abnormality of lumbar spinelike kyphoscoliosis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| first pass success rate in midline and paramedian approach of ultrasound assisted spinal anesthesia in elderly patients undergoing elective lower abdominal, perineal and lower extremity surgeries under spinal anesthesia |
Immediately following successful csf tap after providing spinal through the specific ultrasound assisted approach |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare the number of needle passes between midline & paramedian group
Compare the number of spinal needle insertion attempts between midline & paramedian group
Compare the total procedure time between midline & paramedian group
Compare the the incidence of radicular pain , paresthesia , & bloody tap during the neuraxial procedure between midline & paramedian group |
Immediately following successful csf tap after providing spinal through the specific ultrasound assisted approach |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/11/2025 |
| 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)
|
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 study aims to compare the midline vs paramedian approach of ultrasound assisted spinal anesthesia in elderly population posted for elective lower limb abdominal and perineal surgeries under regional anesthesia ultrasound is an emerging and very useful modality perioperatively and becomes very useful in the elderly population with difficult anatomical landmarks of spine for administering anesthesia various approaches are studied looking for the first pass success rate and number of passes as the outcomes mainly out of many other |