| 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
|
|
|
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
|
|
|
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. |