| CTRI Number |
CTRI/2025/02/081219 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Measuring depth of epidural space using USG in Transverse median and parasagittal views |
|
Scientific Title of Study
|
Accuracy of measuring depth of epidural space using Ultrasound imaging in Transverse median and parasagittal oblique planes in patients scheduled for surgery under general anaesthesia and lumbar epidural anaesthesia - an observational 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 |
K Aaromal Muttakulath |
| Designation |
MD resident |
| Affiliation |
Kidwai Memorial institute of Oncology |
| Address |
Department of Anaesthesiology and pain relief, Kidwai memorial institute of oncology, Bengaluru 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
8137980185 |
| Fax |
|
| Email |
draaromal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V B Gowda |
| Designation |
Professor |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Department of Anaestheisa, Ot complex building, kidwai hospital campus, Dr M H marigowda road, Bengaluru 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9845259264 |
| Fax |
|
| Email |
vbchethana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V B Gowda |
| Designation |
Professor |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Department of Anaestheisa, Ot complex building, kidwai hospital campus, Dr M H marigowda road, Bengaluru 560029
KARNATAKA
560029
India |
| Phone |
9845259264 |
| Fax |
|
| Email |
vbchethana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kidwai Memorial Institute of Oncology, Bangalore, karnataka, India. pin 560029 |
|
|
Primary Sponsor
|
| Name |
Dr Aaromal |
| Address |
#203, KMIO mens pg hostel, Dr M H Marigowda Road, bengaluru 560029 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr K Aaromal Muttakulath |
Kidwai Memorial institute of oncology |
Department of Anaesthesiology and pain relief, Ot Block, Kidwai Memorial institute of oncology, Dr M H Marigowda Road, Bangalore 560029
Bangalore
KARNATAKA |
8137980185
draaromal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 16-65 years.
Patients belonging to ASA physical status grade 1 and 2.
Patients consenting for study.
Patientd having BMI of 18.5-30 kg. m-2 |
|
| ExclusionCriteria |
| Details |
Patient’s refusing epidural anaesthesia.
Patients belonging to ASA physical status grade III and IV.
With a history of previous spinal surgery.
Anticipated difficult spinal block.
Infection at the puncture site.
Coagulopathies.
Any other contraindication to neuraxial block. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Precision of measurement of the skin to posterior complex depth(UD) in both the planes (UD-PSO and UD-TM) as compared to the depth measured during actual needle insertion (ND-PSO and ND-TM). |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Accuracy of determining the insertion point as gauged by the number of reinsertions
(change of puncture site) & needle redirections |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
05/03/2025 |
| 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="2"
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
|
The meticulous practice of ultrasound scanning for central neuraxial block has been well defined in literature. The efficacy of ultrasound imaging in determining the depth of epidural space has been extensively documented by comparing the ultrasound depth (UD) in various axes to the actual needle depth (ND). Ultrasound aids in identification of intervertebral levels, estimation of the depth to epidural and intrathecal spaces, and location of important landmarks, including the midline and interlaminar spaces. This can facilitate neuraxial blockade, particularly in patients with difficult surface anatomic landmarks. This study is designed to compare the efficacy of US imaging in the transverse median (TM) and paramedian sagittal oblique (PSO) planes in accurately predicting the depth to epidural space and the point of needle insertion for epidural needle placement in patients scheduled for surgery |