| CTRI Number |
CTRI/2024/07/070560 [Registered on: 13/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
If by using ultrasonography the distance of transverse process and epidural space are similar to the actual depth of epidural space |
|
Scientific Title of Study
|
Relationship between ultrasound estimated depths of transverse process and epidural
space in lumbar region to the actual depth of epidural space in adult patients – a
prospective 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 |
Rigzin Angmo Karpa |
| Designation |
PG resident |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anesthesia/ Room 332/ House surgeon block/ lady Hardinge medical college C4/111 Safdarjung development area. Hauz Khas New Delhi DELHI 110001 India |
| Phone |
7042809739 |
| Fax |
|
| Email |
angmorigzin07@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Upma Bhatia Batra |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg
New Delhi
New Delhi DELHI 110001 India |
| Phone |
9868616048 |
| Fax |
|
| Email |
ubhatia2004@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Upma Bhatia Batra |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg
New Delhi
New Delhi DELHI 110001 India |
| Phone |
9868616048 |
| Fax |
|
| Email |
ubhatia2004@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Lady Hardinge Medical College
New Delhi
110001
India |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Shaheed Bhagat singh Marg
New Delhi 110001
India |
| Type of Sponsor |
Government 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 |
| Rigzin Angmo Karpa |
Lady Hardinge Medical College and ass hospitals |
Department of anaesthesia, shaheed Bhagat singh marg, 110001 Central DELHI |
7042809739
angmorigzin07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Human Research,LHMC and Assoc. Hospitals |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) physical status I or II adult patients receiving epidural anaesthesia for elective surgery
|
|
| ExclusionCriteria |
| Details |
1 Obvious spine deformity
2 History of spine surgery
3 Infection at needle insertion site
4 Coagulopathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 Concordance correlation coefficient between ultrasound estimated depths of transverse process and epidural space in lumbar region to the actual depth of epidural space in adult patients |
1 After removal of epidural needle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Bias, precision and agreement between ultrasound estimated depths of transverse process and epidural space in lumbar region to the actual depth of epidural space in adult patients
2 Spearman coefficient between the depth of lumbar transverse process and needle insertion depth with the BMI of the patient.
3 Percentage of patients having successful first pass attempt.
4 Median Interquartile range (IQR) of ultrasound visualization score (UVS). |
1 After removal of epidural needle
2 After removal of epidural needle
3 After removal of epidural needle
4 During pre procedural ultrasonography of spine |
|
|
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)
|
25/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="1" Days="18" |
|
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
|
Ultrasound (US) guidance has revolutionized the practice of regional anaesthesia and its use in neuraxial anaesthesia has shown to improve the ease and accuracy of performance of neuraxial blocks. The routine use of US for neuraxial anesthesia was not formally accepted until 2008 when the National Institute for Health and Care Excellence recommended it for epidural catheterizations.1 Systematic examination of the spine sonoanatomy provides valuable anatomical information such as the identity of given vertebral level, the depth of epidural space and the location of midline of the interspinous and interlaminar spaces in sagittal and transverse planes. Various studies have found excellent correlation between the US estimated depth (UD) to the epidural space and the actual needle depth (ND) in transverse median (TM) and paramedian sagittal oblique (PSO) planes across variable patient populations.2,3 However, the US guided technique is not without its limitations. Imaging the vertebral canal in the US(ligamentum flavum, dura mater, and posterior aspect of the vertebral body) can be difficult in the same patient populations in which it is most required. In cases of obesity, spinal deformity or previous surgeries or instrumentation of the spine, oedema of the back; it becomes difficult to image various neural structures optimally.4 Therefore, there is a need for establishing easily visible surrogate landmarks to guide towards depth assessment of epidural space especially for less experienced users. In the lumbar region, anatomically the horizontal level of the transverse process corresponds to the level of the intervertebral space through which epidural and sub arachnoid spaces can be accessed.5 In the US guided transverse inter laminar view of the spine the transverse process and the articular process lie in approximately the same transverse plane as the posterior complex. So, measuring the depth of the posterior margin of transverse process from the skin surface may corroborate with the depth of the posterior complex from the skin, when the posterior complex is either not visualized or poorly visualized.In patients with difficult surface anatomical landmarks, visualization of sonoanatomy may also be difficult.6 So, there is a need to identify surrogate markers of neural structures that are relatively easy to image. At the lumbar level, the transverse process is one such landmark. We aimed to conduct the present study to estimate the relationship between ultrasound estimated depths of transverse process and epidural space in lumbar region to the actual needle depth of epidural space in adult patients which is the gold standard for epidural space depth measurement |