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CTRI Number  CTRI/2025/10/096420 [Registered on: 23/10/2025] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluates the safety and efficacy of spinal anaesthesia, peripheral nerve block, and monitored anaesthesia care for day care varicose vein surgery 
Scientific Title of Study   Comparison of efficacy and safety profile of spinal anaesthesia, peripheral nerve block and monitored anaesthesia care for day care varicose vein surgery: A prospective randomized controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anamika Shukla 
Designation  Junior Resident 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology Gandhi memorial and Associated Hospital King George Medical University Shahmina road
Chowk Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India 
Phone  9695961119  
Fax    
Email  anamikashukla0208@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Rajni Gupta 
Designation  Professor 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology Gandhi memorial and Associated Hospital King George Medical University Shahmina road
Chowk Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India 
Phone  9839288980  
Fax    
Email  rgkgmu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Rajni Gupta 
Designation  Professor 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology Gandhi memorial and Associated Hospital King George Medical University Shahmina road
Chowk Lucknow Uttar Pradesh

UTTAR PRADESH
226003
India 
Phone  9839288980  
Fax    
Email  rgkgmu@gmail.com  
 
Source of Monetary or Material Support  
Room No 1 Department of Anaesthesiology Gandhi Memorial and Associated Hospital King george Medical university shahmina road Chowk Lucknow 226003 Uttar Pradesh 
 
Primary Sponsor  
Name  Operation Theater King George Medical University 
Address  Department of Anaesthesiology and Department of surgery Gandhi memorial and Associated Hospital King George Medical University Shahmina road Chowk Lucknow 226003 Uttar Pradesh  
Type of Sponsor  Government medical college 
 
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 
Prof Rajni Gupta  King George Medical University Lucknow  Room No 1 Department of Anaesthesiology Gandhi memorial and Associated Hospital King George Medical University Shahmina road Chowk Lucknow 226003 Uttar Pradesh
Lucknow
UTTAR PRADESH 
9839041228

rgkgmu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I838||Varicose veins of lower extremities with other complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1. To compare the Hemodynamics during perioperative period 2. To compare the time of ambulation and time of void 3. To compare the patient satisfaction score using Iowa Satisfaction with Anesthesia Scale 4. Length of hospital stay 5. Complications during perioperative period   1. Surgeon’s satisfaction based on Likert scale 2. Patient satisfaction using Iowa Satisfaction with Anaesthesia Scale(ISAS) 3. Changes in hemodynamic parameters - BP, Heart rate 4. Recovery data • Time of possible ambulation (hr) • Intention to have same anaesthesia • Nausea or vomiting • Post-operative VAS pain score 5. Complications • Hypotension • Hypertension • Bradycardia • Tachycardia • Hypoxia  
Intervention  Monitored Anaesthesia Care  loading dose of 1 microgram per kg of dexmedetomidine was administered over 10 minutes, followed by a maintenance infusion beginning at a rate of 0.2-0.7 micgmper kg per hr. Sedation state will be assessed every 5 minutes, and the infusion rate of the drug will be titrated to maintain an OAA/S score of 4 or less throughout the surgery. 
Intervention  Peripheral nerve block using 0.75% isobaric Ropivacaine   Femoral nerve block will be performed using a linear US transducer, while saphenous nerve block will involve locating femoral vessels in the sub sartorial canal and injecting 12ml of 0.75% Ropivacaine all around the nerve without puncturing the nerve. Sciatic nerve block will be performed by identifying popliteal vessels in the popliteal fossa and injecting 12ml of 0.75% Ropivacaine. Motor block will be assessed by evaluating muscle weakness, and patients will be asked to actively dorsi and plantar flex the foot (after femoral block) or flex-extend the knee (after sciatic block) and flex the hip 
Intervention  Spinal anaesthesia using Hyperbaric Ropivacaine 0.75%   Spinal anesthesia will be administered using Hyperbaric Ropivacaine 0.75% 15mg with 0.4 ml fentanyl in the L3-L4 or L4-L5 intervertebral space using a 25 G Quincke’s needle under aseptic conditions. Midazolam will be administered intravenously after 15 minutes of injecting intrathecal local anesthetic drugs. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients scheduled for saphenous varicose vein surgery.
Age between 18 and 70 years.
ASA I - II
Written Informed consent will be taken.
 
 
ExclusionCriteria 
Details  Patient Refusal
Known allergy to components of the anesthesia drugs.
History of coagulopathy or bleeding disorders.
History of drug abuse or chronic sedative use
High cardiovascular risk
Significant pulmonary disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy: Postoperative pain scores (VAS/NRS) at different time intervals, time to first analgesic request, duration of analgesia.
Safety: Incidence of anesthesia-related complications (hypotension, bradycardia, respiratory depression), postoperative nausea and vomiting (PONV), need for unplanned hospital admission. 
2 to 24hrs 
 
Secondary Outcome  
Outcome  TimePoints 
Recovery parameters: Time to ambulation, discharge readiness, patient satisfaction scores.
Adverse events: Incidence of deep vein thrombosis (DVT), surgical site infection, anaphylaxis.
Analgesic requirement: Total opioid consumption in 24 hours post-surgery. 
2 to 24 hrs 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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   N/A 
Date of First Enrollment (India)   18/11/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

AIMS AND OBJECTIVES

The study aims to compare the efficacy and safety profiles of spinal anesthesia, peripheral nerve block, and monitored anesthesia care in varicose vein surgery. It focuses on surgeon satisfaction using the Likert scale, hemodynamics during the perioperative period, time of ambulation and void, patient satisfaction using the Iowa Satisfaction with Anesthesia Scale, length of hospital stay, and complications during the perioperative period.

MATERIAL AND METHODS

The study will be conducted at King George’s Medical University, Lucknow, with a prospective, randomized controlled design. The study will last 18 months, with 33 participants in each group. The study will include 99 cases scheduled for saphenous varicose vein surgery, aged 18-70, with written informed consent. Exclusion criteria include patient refusal, known allergies to anesthesia components, history of bleeding disorders, drug abuse, high cardiovascular risk, and significant pulmonary disease.

The study will be conducted at King George Medical University, Lucknow, using computer-generated random numbers to ensure a balanced distribution of potential confounding factors. Participants will be randomly divided into three groups: Group A (spinal anesthesia), Group B (peripheral nerve block), and Group C (monitored anesthesia care). Spinal anesthesia will be administered using Hyperbaric Ropivacaine 0.75% 15mg with 0.4 ml fentanyl in the L3-L4 or L4-L5 intervertebral space using a 25 G Quincke’s needle under aseptic conditions. Midazolam will be administered intravenously after 15 minutes of injecting intrathecal local anesthetic drugs. Group B (peripheral nerve block) will be determined by the location of varices. Femoral nerve block will be performed using a linear US transducer, while saphenous nerve block will involve locating femoral vessels in the sub sartorial canal and injecting 12ml of 0.75% Ropivacaine all around the nerve without puncturing the nerve. Sciatic nerve block will be performed by identifying popliteal vessels in the popliteal fossa and injecting 12ml of 0.75% Ropivacaine. Laser ablation will be started approximately five minutes after nerve blocks. Motor block will be assessed by evaluating muscle weakness, and patients will be asked to actively dorsi and plantar flex the foot (after femoral block) or flex-extend the knee (after sciatic block) and flex the hip in frequent cycles until they could walk. A Visual Analogue Pain Scale will be employed for assessment of procedural pain in all cases. In Group C, a loading dose of 1 micgmper kg of dexmedetomidine was administered over 10 minutes, followed by a maintenance infusion beginning at a rate of 0.2-0.7 micgmper kg per hr. Sedation state will be assessed every 5 minutes, and the infusion rate of the drug will be titrated to maintain an OAA/S score of 4 or less throughout the surgery. All patient’s perioperative data, including procedure duration, anesthesia onset time, hemodynamic parameters, postoperative pain scores, intra-operative vital signs, cognitive dysfunction, adverse events, and satisfaction of patients and surgeons using the Likert Scale, will be noted. Continuous monitoring of vital signs during surgery and postoperative periods will take place, and adverse events or complications related to each anesthesia method will be recorded.

The outcome assessment includes surgeons’ and patient satisfaction using the Likert scale, changes in hemodynamic parameters, recovery data, time of possible ambulation, intention to use the same anesthesia, nausea or vomiting, post-operative VAS pain score, and complications such as hypertension, bradycardia, tachycardia, and hypoxia.

Statistical analysis

The data will be analyzed using SPSS and MS Excel, with continuous variables expressed as mean standard deviation. Counting data will be expressed as number and percentages. Intergroup comparisons will be made using unpaired and paired t tests, while the chi square test will compare proportion data between groups. Statistical significance will be determined at P less than 0.05. 
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