| CTRI Number |
CTRI/2025/06/089248 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ultrasound Guided Epidural Depth assessment
Between Transverse Median Plane and landmark approch And Parasagittal Oblique Plane and landmark approch For Lower Thoracic Epidural.
|
|
Scientific Title of Study
|
Ultrasound Guided Epidural Depth Estimates :
A Comparison Between Transverse Median Plane And Parasagittal Oblique Plane For Lower Thoracic Epidural |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitishree Tyagi |
| Designation |
Resident Anaesthesia |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department Of Anaesthesiology and pain management, SRHU
HIMS, Jolly Grant Dehradun, 248140 India
Dehradun UTTARANCHAL 248140 India |
| Phone |
9999722706 |
| Fax |
|
| Email |
drnitishree@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rohan Bhatia |
| Designation |
Professor |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department Of Anaesthesiology and pain management, SRHU
HIMS, Jolly Grant Dehradun, 248140 India
Dehradun UTTARANCHAL 248140 India |
| Phone |
9971014232 |
| Fax |
|
| Email |
rohanbhatia@srhu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Rohan Bhatia |
| Designation |
Professor |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department Of Anaesthesiology and pain management, SRHU
HIMS, Jolly Grant Dehradun, 248140 India
Dehradun UTTARANCHAL 248140 India |
| Phone |
9971014232 |
| Fax |
|
| Email |
rohanbhatia@srhu.edu.in |
|
|
Source of Monetary or Material Support
|
| Swami Rama Himalayan University Jolly Grant, Dehradun, 248140 |
|
|
Primary Sponsor
|
| Name |
Swami Rama Himalayan University |
| Address |
SRHU HIMS, Jolly Grant, Dehradun 248140, Uttrakhand, India |
| 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 |
| Rohan Bhatia |
Swami Rama Himalayan Institute, HIMS |
Department Of
Anaesthesiology And
Pain Management, Fisrt
Floor, HIMS SRHU,
Jolly Grant 248140
Dehradun, UK, India
Dehradun
UTTARANCHAL Dehradun UTTARANCHAL |
9971014232
rohanbhatia@srhu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SWAMI RAMA HIMALAYAN UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Parasagittal Oblique Plane |
This is the newer or less conventional approach that is often considered as the intervention in comparative studies |
| Comparator Agent |
Transverse Median Plane |
This is typically the standard or more commonly used technique, and hence serves as the comparator |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologist (ASA) physical status grade I and II posted for elective surgical procedures of general surgery, urological and gynaecological surgeries under lower thoracic epidural anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient refusal for Regional Anaesthesia.
Known allergies to Local anaesthetics.
Bleeding disorders
Infection at local site
BMI above 30 kg/m2
Inability to give informed consent
Psychiatric Disorder
Patient with neurological diseases
History of spinal surgery
Pregnant females
Deformities of the spine and any other contraindication to neuraxial block will be excluded from this study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate skin epidural depth as assessed by ultrasound (UD) & conventional technique Needle depth (ND) in Transverse median plane & Parasagittal Oblique plane. |
15-20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the accuracy of needle depth (ND) and ultrasound guided epidural depth (ED) in Transverse median plane and Parasagittal oblique plane .
Correlation between Body Mass Index (BMI) and skin epidural depth in both the planes. |
15-20 minutes |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
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)
|
30/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/06/2025 |
| 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 Applicable |
| 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
|
Epidural analgesia is a form of regional analgesia which involving the drugs through injection or a catheter placed in the epidural space.It is still considered as a gold standard for perioperative pain management in major abdominal and thoracic surgeries as it improves the postoperative outcome. Advantage includes a lower risk of postoperative myocardial infarction, better pulmonary mechanics and decreased hyper-coagulable reaction to stress which all lead to better recovery after surgery (1 ,2).Epidural analgesia through an indwelling catheter decreases intra and postoperative opioid usage (3). It has been observed that in Thoracic and Intra-abdominal surgeries the incidence of postoperative gastrointestinal dysfunction, sedation and respiratory depression were reduced with continuous Thoracic Epidural Analgesia (TEA). TEA was linked to early ambulation, improved recovery throughout the peri-operative phase with decreased need of analgesia. TEA also promotes better control of neuroendocrine stress response in intraoperative phase due to protein catabolism and reduced insulin resistance hence aiding in better pain control management (4). It is difficult to access the Thoracic epidural space using the standard anatomic landmark-based Loss Of Resistance (LOR) technique because of spinous processes have a sharp caudal angle and the laminae are densely packed on top of one another , resulting in very limited inter laminar space. Therefore adopting the anatomic landmark based technique for thoracic epidural makes it technically more challenging.And it may leads to” multiple attempts and a relatively higher failure rate (12-40%) which increases patient discomfort and morbidity (5).Nowadays, ultrasound based localisation of the epidural space has become a popular teaching tool. Ultrasonography is useful in planning the insertion angle for the needle trajectory, seeing the anatomy and measuring the depth from the skin to the epidural space therefore it reduces the failure rate, improves learning curve and decrease puncture attempts (6).Ultrasound guided lumbar epidural has gained popularity as it is easily performed, provides opportunity to confirm the landmarks and deposit the local anaesthetic at correct place besides being associated with improved safety and decreased rate of complications. To visualise the lumbar epidural space Ultrasound imaging of the spine is performed in transverse axial plane at the level of desired intervertebral space (7).Use of thoracic epidurals for intra and postoperative analgesia for open abdominal surgeries has exponentially increased over the last decade mainly using conventional methods based on loss of resistance technique (8).Ultrasound guided epidural depth assessment has been primarily used for lumbar region (9). So far, the data on use of ultrasound guided assistance in Thoracic region for depth assessment in both transverse median plane and parasagittal oblique plane is very limited. Therefore, with this background we are planning to evaluate skin epidural depth assessment with conventional loss of resistance technique with ultrasound to assess the accuracy of ultrasound in both the planes. |