A clinical trial to study the safety and effectiveness of the two techniques including only femoral nerve block and obturator nerve combined with femoral nerve block for the relief of procedural pain in patients who undergo Endovenous Laser Ablation of Great Saphenous Vein for varicose veins

Double Blinded Randomized Controlled Trial evaluating the feasibility, safety and efficacy of Obturator Nerve combined with Femoral Nerve Block for analgesia in patients with varicose veins being treated by Endovenous Laser Ablation of Great Saphenous Vein

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056415

Enrollment

120

Registered

2023-08-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: I838- Varicose veins of lower extremities with other complications

Interventions

Intervention1: Ultrasound guided nerve block: For the Femoral nerve block, patient will be asked to lie supine. After cleaning and draping, the common femoral artery (CFA) and common femoral vein (CFV

10 ml will be placed deep and 10 ml superficial to the nerve. For the Obturator nerve block, the ultrasound probe will be aligned along the inguinal crease to visualise the adductor muscle group, then

10 ml will be placed deep and 10 ml superficial to the nerve or in the interfascial region. For EVLA procedure, target vein will be accessed using ultrasonography guidance. Femoral and Obturator nerv

Eligibility

Inclusion criteria

Inclusion criteria: Age 18-75years, C2-6, Ep, As, according to the CEAP classification [clinical, etiologic, anatomical, and pathophysiological (CEAP)] Primary signs and symptoms of truncal(saphenous, accessory, non saphenous) vein incompetence/relux with reflux time of 1 sec or more on Doppler, and diameter of varicose veins more than 3mm and less than 15mm.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
To compare the pain experienced during the Endovenous Laser Ablation procedure, for varicose veins, using a visual analogue pain assessment scale(1-10) in patients receiving obturator and femoral nerve block and tumescent anesthesia vs. patients receiving femoral nerve block and tumescent anesthesia vs. no nerve lock and tumescent anesthesia alone.Timepoint: Immediately after, 24 hours, 1 week, 4 weeks, 3 months and 6 months after the procedure	—

Measure

Time frame

To compare the pain experienced during the Endovenous Laser Ablation procedure, for varicose veins, using a visual analogue pain assessment scale(1-10) in patients receiving obturator and femoral nerve block and tumescent anesthesia vs. patients receiving femoral nerve block and tumescent anesthesia vs. no nerve lock and tumescent anesthesia alone.Timepoint: Immediately after, 24 hours, 1 week, 4 weeks, 3 months and 6 months after the procedure

—

Secondary

Measure	Time frame
Efficacy of femoral block alone in comparison to obturator plus femoral nerve block for pain reduction using visual analogue pain assessment scale9(1-10) will be assessedTimepoint: During the course of procedure	—

Countries

India

Contacts

Public ContactGirish NK

All India Institute of Medical Sciences(AIIMS) New Delhi

sanjeevradio@gmail.com9958456103

Outcome results

None listed

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