| CTRI Number |
CTRI/2026/02/104057 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing the Epifaith syringe versus the conventional LOR syringe for the identification of the epidural space |
|
Scientific Title of Study
|
A Study to compare the Epifaith syringe versus the conventional LOR syringe for the identification of the epidural space |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritu Baloda |
| Designation |
Associate Professor |
| Affiliation |
Pt B.D.Sharma PGIMS |
| Address |
B-261, SECTOR-35 SUNCITY Rohtak Haryana
B-261, SECTOR-35 SUNCITY Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8427666673 |
| Fax |
|
| Email |
ritubaloda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRitu Baloda |
| Designation |
Associate Professor |
| Affiliation |
Pt B.D.Sharma PGIMS |
| Address |
B-261, SECTOR-35 SUNCITY Rohtak Haryana
B-261, SECTOR-35 SUNCITY Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8427666673 |
| Fax |
|
| Email |
ritubaloda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRitu Baloda |
| Designation |
Associate Professor |
| Affiliation |
Pt B.D.Sharma PGIMS |
| Address |
B-261, SECTOR-35 SUNCITY Rohtak Haryana
B-261, SECTOR-35 SUNCITY Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8427666673 |
| Fax |
|
| Email |
ritubaloda@gmail.com |
|
|
Source of Monetary or Material Support
|
| there is no monetory sponsor in this trial |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 |
| DrRitu Baloda |
Pt B.D.Sharma PGIMS |
Modular OT complex,2nd flooe,Department of Anaesthesia,PGIMS,
Rohtak Haryana
Rohtak
HARYANA |
8427666673
ritubaloda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adults posted for elective surgeries requiring epidural anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 years and older
2. Surgery requiring epidural anesthesia or analgesia
3. ASA Physical Status 1 to 3
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacies of the EpiFaith syringe and the conventional syringe for the successful localization of the epidural space |
time required for epidural localization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Time to identify the epidural space
b. Duration of the epidural space localizationNumber of attempts
c. Number of occurrences of false positive
d. The distance from the skin to the epidural space
|
time to identify the epidural space |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
10/03/2026 |
| 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="6"
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 EpiFaith syringe is a recently developed, spring-loaded, loss of resistance (LOR) syringe that can apply different degrees of constant syringe pressure while the operator is advancing the epidural needle, which releases when the epidural space is reached. It provides objective and quantitative pressure information as well as a visual signal, which is triggered when the needle tip enters the epidural space.The study hypothesizes that the EpiFaith syringe can detect the LOR of the epidural space effectively with its achievable pressure. •This is a single blind, randomized observational study. Subjects who will receive a surgery requiring epidural anesthesia or analgesia and meet all of the study criteria will be enrolled in the study after giving informed consent. After screening, eligible subjects will be randomly assigned to one of the following groups: Group 1: detection by EpiFaith syringe; Group 2: detection by LOR syringe. The following variables will be recorded and rated during the process of epidural space localization: Success of epidural localization, time to identify the epidural space, duration of the epidural space localization procedure, number of attempts, number of the occurrence of false positive, the distance from the skin to the epidural space, and number of change insertion segment. Adverse events and concomitant treatments will also be recorded. |