| CTRI Number |
CTRI/2025/08/092914 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study in Adult Surgical Patients to Test if the Swirl Sign Can Accurately Confirm Correct Epidural Catheter Placement for Pain Relief |
|
Scientific Title of Study
|
A Prospective, Randomized Controlled Trial Evaluating the Diagnostic Utility of the Swirl Sign for Epidural Catheter Placement Confirmation in Adult Surgical Patients (The EPICS Trial) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gautham Patel |
| Designation |
Associate Consultant |
| Affiliation |
HOSMAT Multispeciality Hospital |
| Address |
HOSMAT Multispeciality Hospital, Department of Anesthesia and Intensive Care,
45, Magrath Rd, Ashok Nagar, Bengaluru, Karnataka 560025
Bangalore
KARNATAKA
560025
India |
| Phone |
9731247600 |
| Fax |
|
| Email |
gauthampatel.gp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautham Patel |
| Designation |
Associate Consultant |
| Affiliation |
HOSMAT Multispeciality Hospital |
| Address |
HOSMAT Multispeciality Hospital,
Department of Anesthesia and Intensive Care,
45, Magrath Rd, Ashok Nagar, Bengaluru, Karnataka 560025
Bangalore
KARNATAKA
560025
India |
| Phone |
9731247600 |
| Fax |
|
| Email |
gauthampatel.gp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautham Patel |
| Designation |
Associate Consultant |
| Affiliation |
HOSMAT Multispeciality Hospital |
| Address |
HoOSMAT Multispeciality Hospital,
Department of Anesthesia and Intensive Care,
45, Magrath Rd, Ashok Nagar, Bengaluru, Karnataka 560025
Bangalore
KARNATAKA
560025
India |
| Phone |
9731247600 |
| Fax |
|
| Email |
gauthampatel.gp@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
HOSMAT Multispeciality Hospital |
| Address |
45, Magrath Rd, Ashok Nagar, Bengaluru, Karnataka 560025 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Gautham Patel |
HOSMAT Multispeciality Hospital |
Department of Anesthesia and Intensive Care, 1st floor, Operation theatre, 45, Magrath Rd, Ashok Nagar, Bengaluru, Karnataka 560025
Bangalore
KARNATAKA |
9731247600
gauthampatel.gp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee HOSMAT |
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 |
Standard clinical confirmation
|
After loss-of-resistance and catheter insertion, correct placement is confirmed using conventional clinical methods (e.g., aspiration test, test dose) without ultrasound visualization.
|
| Intervention |
Swirl Sign technique |
After loss-of-resistance and catheter insertion, normal saline is injected into the catheter and observed under real-time ultrasound for the “swirl sign” in the epidural space as confirmation of correct placement. Performed in adult surgical patients under planned epidural anesthesia.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (ASA I–III) undergoing elective surgeries under epidural anesthesia who provide informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with coagulopathy, local infection at puncture site, spinal deformity, prior spine surgery, allergy to local anesthetics, pregnancy, inability to provide informed consent, or requiring combined spinal-epidural anesthesia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy of the swirl sign for confirming correct epidural catheter placement (sensitivity, specificity, positive predictive value, negative predictive value). |
1. Immediately after epidural catheter placement confirmation (baseline).
2. At 5 minutes post-catheter placement.
3. At the end of the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for confirmation of correct catheter placement |
immediately after insertion. |
| Number of attempts for catheter placement |
Intraoperative |
| Incidence of failed epidural block |
within 30 minutes after drug administration. |
| Complications related to catheter placement (e.g., dural puncture, intravascular placement) |
Intraoperative |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| Date of Study Completion (India) |
20/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This prospective, randomized controlled trial aims to evaluate the diagnostic accuracy of the swirl sign for confirming correct epidural catheter placement in adult surgical patients. Sixty patients scheduled for elective surgeries under combined spinal-epidural anesthesia will be randomized into two groups. In the study group, the swirl sign will be used to confirm catheter placement; in the control group, traditional methods such as test dose and aspiration will be used. The primary outcome is the diagnostic accuracy of the swirl sign compared to the reference standard of successful block. Secondary outcomes include time taken for confirmation, number of attempts, and incidence of complications. The study will be conducted at a single tertiary care hospital in India over a period of six months.
|