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Study in Adult Surgical Patients to Test if the Swirl Sign Can Accurately Confirm Correct Epidural Catheter Placement for Pain Relief

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)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092914
Enrollment
60
Registered
2025-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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 ep

Sponsors

HOSMAT Multispeciality Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients (ASA I III) undergoing elective surgeries under epidural anesthesia who provide informed consent.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of the swirl sign for confirming correct epidural catheter placement (sensitivity, specificity, positive predictive value, negative predictive value).Timepoint: 1. Immediately after epidural catheter placement confirmation (baseline). 2. At 5 minutes post-catheter placement. 3. At the end of the procedure.

Secondary

MeasureTime frame
Time taken for confirmation of correct catheter placementTimepoint: immediately after insertion.;Number of attempts for catheter placementTimepoint: Intraoperative;Incidence of failed epidural blockTimepoint: within 30 minutes after drug administration.;Complications related to catheter placement (e.g., dural puncture, intravascular placement)Timepoint: Intraoperative

Countries

India

Contacts

Public ContactDr Gautham Patel

HOSMAT Multispeciality Hospital

gauthampatel.gp@gmail.com9731247600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026