| CTRI Number |
CTRI/2025/09/094159 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
USG vs Palpatory method for Spinal in Infra-Umbilical Surgeries. |
|
Scientific Title of Study
|
USG Assisted Versus Surface Landmark Technique For Subarachanoid Block In Patients Undergoing Infra Umbilical Surgeries. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renganathan Sockalingam |
| Designation |
Associate Professor |
| Affiliation |
VELAMMAL MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no 2 ,Clinical Division,Department of Anesthesia Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu 625009
Madurai TAMIL NADU 625009 India |
| Phone |
09500025879 |
| Fax |
|
| Email |
renganathansockalingam@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Renganathan Sockalingam |
| Designation |
Associate Professor |
| Affiliation |
VELAMMAL MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no 2 ,Clinical Division,Department of Anesthesia Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu 625009
TAMIL NADU 625009 India |
| Phone |
09500025879 |
| Fax |
|
| Email |
renganathansockalingam@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Renganathan Sockalingam |
| Designation |
Associate Professor |
| Affiliation |
VELAMMAL MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room no 2 ,Clinical Division,Department of Anesthesia Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu 625009 Annupanadi
TAMIL NADU 625009 India |
| Phone |
09500025879 |
| Fax |
|
| Email |
renganathansockalingam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 2 ,Clinical Division,Department of Anesthesia Velammal medical college and Research Institute ,Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu India 625009 |
|
|
Primary Sponsor
|
| Name |
Velammal Medical College |
| Address |
Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu 625009 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| C Navin |
Velammal Medical college and hospital |
Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Tamil Nadu 625009
Annupanadi Madurai TAMIL NADU |
09500025879
navin.immortals@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VELAMMAL MEDICAL COLLEGE AND RESEARCH INSTITUTE |
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 |
| Comparator Agent |
Landmark Guided SAB in Infra Umblical Surgeries |
Patient Positioning: The patient is typically placed in a sitting or lateral decubitus (on their side) position.
Identifying Landmarks: The primary landmark used is the Tuffiers line, an imaginary line connecting the highest points of the iliac crests (the bony prominences on the hips).
Spinal Interspace: Tuffiers line generally corresponds to the L4 vertebral body or the L4-L5 intervertebral space. The procedure is usually performed at the L3-L4 or L4-L5 interspaces, as the spinal cord typically ends at the L1-L2 level in adults, making these spaces safer for needle insertion.
Needle Insertion: The anesthesiologist palpates the spinous processes of the vertebrae and inserts the spinal needle into the chosen interspace, either using a midline or paramedian approach. The correct placement is confirmed by the free flow of cerebrospinal fluid (CSF). |
| Intervention |
USG Assisted SAB in Infra Umblical Surgeries |
Pre-procedural Scan: The anesthesiologist places a low-frequency ultrasound probe on the patients back to obtain images of the lumbar spine.
Identifying Structures: They identify the spinous processes, laminae, and the posterior dura, which appears as a bright, hyperechoic line. The intervertebral spaces are located as "acoustic windows" between the bony structures.
Marking the Site: Once the correct intervertebral space is identified (usually L3-L4 or L4-L5 for infra-umbilical surgeries), the anesthesiologist marks the precise midline insertion point and the optimal angle for the needle.
Needle Insertion: The spinal needle is then inserted at the marked site, guided by the pre-procedural scan and the measured depth to the dura. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA class I & II posted for elective infraumbilical surgeries requiring Subarachnoid block |
|
| ExclusionCriteria |
| Details |
-patient refusal
-Bleeding diathesis
-contraindicated for spinal anesthesia
-patient with systemic or localized infection at
puncture site.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| first pass needle success rate. |
It is the time calculated in seconds from the first skin puncture with the spinal needle to free flow of CSF. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
number of needle puncture attempts.
2.time taken to establish landmarks.
3.time taken to accomplish SAB
|
1.number of times needle was taken out of the skin & redirected for free flow of csf
2.time taken to establish puncture point before needle entry either using usg or landmark in seconds
3.time taken to accomplish desired sensory & motor level |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
In USG group, ultrasound scanning in sitting position was done in preoperative room by an anesthesiologist. An ultrasound probe was placed transversely in the midline in the lumbar region to visualize the best view of the spinous process which appeared linear hypoechoeic acoustic shadow. Using M mode of USG L4-L5 and L3-L4 interlaminar space identified and marked using a surgical skin marking pen. Patient shifted to operation room and again in sitting position, 25G Quincke’s spinal needle was introduced in the marked point maintaining the same angle in which the USG probe was kept and subarachnoid space location was confirmed by backflow of clear CSF. 2-3 ml of 0.5% hyperbaric bupivacaine was given and patient made to lie down in supine position, Spinal uptake levels checked and surgery proceeded. In the SLG group spine was palpated in the midline and two intervertebral spaces L4-L5 and L3-L4 were palpated and spinal anaesthesia is performed by conventional palpatory surface landmark technique. And 2-3 ml of 0.5% hyperbaric Bupivacaine was given .The first pass needle insertion success and number of needle puncture attempts taken to achieve spinal anaesthesia were recorded.
|