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CTRI Number  CTRI/2020/08/027153 [Registered on: 14/08/2020] Trial Registered Prospectively
Last Modified On: 31/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluation of feasibility, safety and effectiveness of “Femoral Nerve Block” procedure for reduction of pain in patients suffering from varicose veins who are being treated by “Endovenous Laser Ablation of Great Saphenous Vein” 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rishabh Khurana 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Room 10A, Department of Cardiovascular Radiology and Endovascular Interventions

South
DELHI
110029
India 
Phone  9711744049  
Fax    
Email  rishabhkhurana88@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjeev Kumar 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room 10A, Department of Cardiovascular Radiology and Endovascular Interventions

South
DELHI
110029
India 
Phone    
Fax    
Email  sanjeevradio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rishabh Khurana 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Room 10A, Department of Cardiovascular Radiology and Endovascular Interventions

South
DELHI
110029
India 
Phone  9711744049  
Fax    
Email  rishabhkhurana88@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Ansari Nagar East, New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rishabh Khurana  All India Institute of Medical Sciences  Room 10A, Department of Cardiovascular Radiology and Endovascular Interventions
South
DELHI 		 9711744049

rishabhkhurana88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Ethics Committee for Post Graduate Research, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I832||Varicose veins of lower extremities with both ulcer and inflammation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 anaesthesia which eliminates pain during the procedure as well as protects surrounding tissues from thermal injury.The entire EVLA procedure takes approximately 45 minutes 
Intervention  Femoral Nerve Block  Femoral Nerve Block (FNB) is administration of local anesthetic around the femoral nerve under ultrasound guidance for achieving analgesia.  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  1.Any patient who doesn’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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Peri-procedural pain using visual analogue scale (1-10)  Patient will be assessed immediately after completion of EVLA procedure.
 
 
Secondary Outcome  
Outcome  TimePoints 
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) 		 24 hours, 1 week, 4 weeks, 3 months and 6 months after procedure 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   Phase 1 
Date of First Enrollment (India)   17/08/2020 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Varicose veins are the dilated and tortuous veins in the subcutaneous tissue of the leg. It affects more than one-third of general population in their lifetime. Minimally invasive treatment strategy using endovenous laser ablation (EVLA) and/or foam sclerotherapy have replaced open surgery throughout the world. This is because of increased safety, efficacy, faster recovery and better cosmetic results. EVLA is normally performed by using local perivenous tumescent anaesthesia (TA).  The role of TA is to eliminate pain during the EVLA procedure, as well as protect the surrounding tissues from thermal injury due to laser.  However, TA requires multiple punctures along medial aspect of thigh along the course of great saphenous vein (GSV) which may induce pain.  The intensity of this pain is ‘‘tolerable’’ for most patients, but it may be a ‘‘bad experience’’ for the others. Also, this pain may be intense if venous spasm occurs during catheterization. Administering femoral nerve block under ultrasound guidance (US-FNB) is an option to reduce this discomfort. Feasibility, pain control efficiency and safety of US-FNB has been established in the past, and few studies have also been done using this analgesia technique for EVLA procedure as well. However, there is lack of a robust randomised-placebo controlled trial evaluating the same. Hence, we intend to do a single-centre double blinded randomised placebo-controlled trial to evaluate the feasibility, safety and efficacy of USG guided femoral nerve block for EVLA of GSV. 
 
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