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Evaluation of feasibility, safety and effectiveness of â??Femoral Nerve Blockâ?? procedure for reduction of pain in patients suffering from varicose veins who are being treated by â??Endovenous Laser Ablation of Great Saphenous Veinâ??

Double Blinded Randomized Controlled Trial evaluating the feasibility, safety and efficacy of 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 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027153
Enrollment
80
Registered
2020-08-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: I832- Varicose veins of lower extremities with both ulcer and inflammation

Interventions

Intervention1: Endovenous Laser Ablation: Endovenous Laser ablation (EVLA) is a minimally invasive treatment strategy for varicose veins. EVLA is normally performed by using local perivenous tumescent

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.C2-6, Ep, As, according to the CEAP classification [clinical, etiologic, anatomical, and pathophysiological (CEAP)] 2. 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: 1.Any patient who doesnâ??t give consent for being included in the study. 2.Evidence of peripheral arterial disease 3.Any previous treatment, such as surgery, EVLA, radiofrequency ablation, or FS, for ipsilateral varicosity. 4.Lower limb varicosity caused by deep venous thrombosis. 5. Coagulation disorder, pregnancy, lactation, current thrombosis, systemic disease, poor general health

Design outcomes

Primary

MeasureTime frame
Peri-procedural pain using visual analogue scale (1-10)Timepoint: Patient will be assessed immediately after completion of EVLA procedure.

Secondary

MeasureTime frame
1. Motor Block assessment 2. Assess for length of patent GSV distal to SFJ 3. Patency of treated GSV, DVT or any treatment related complication (related to EVLA or femoral nerve block)Timepoint: 24 hours, 1 week, 4 weeks, 3 months and 6 months after procedure

Countries

India

Contacts

Public ContactDr Rishabh Khurana

All India Institute of Medical Sciences

sanjeevradio@gmail.com

Outcome results

None listed

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