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CTRI Number  CTRI/2025/08/093617 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 25/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Surgical/Anesthesia
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   drugs effects in day care varicose vein surgery 
Scientific Title of Study   a randomised controlled study of comparative effect of hyperbaric 0.75% ropivacaine vs hyperbaric 0.75% ropivacaine with fentanyl in day care varicose vein surgery 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhishek Dixit 
Designation  Junior Resident 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology
Department of Anaesthesiology Gandhi Memorial and Associated Hospital, King Georges Medical University Shahmina Road Chowk Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India 
Phone  9602886431  
Fax    
Email  abhishekdixit52@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Rajni Gupta 
Designation  Professor 
Affiliation  King Georges Medical University Lucknow 
Address  Professor
Department of Anaesthesiology Gandhi Memorial and Associated Hospital, King Georges Medical University Shahmina Road Chowk Lucknow 226003
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  Professor
Department of Anaesthesiology Gandhi Memorial and Associated Hospital, King Georges Medical University Shahmina Road Chowk Lucknow 226003

UTTAR PRADESH
226003
India 
Phone  9839288980  
Fax    
Email  rgkgmu@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Gandhi Memorial and Associated Hospital, King Georges Medical University Shahmina Road Chowk Lucknow 226003 
 
Primary Sponsor  
Name  Operation Theater 
Address  Department of Anaesthesiology Gandhi Memorial and Associated Hospital, King Georges Medical University Shahmina Road Chowk Lucknow 226003 
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  Operation theater  Department of Anaesthesiology and department of general surgery Gandhi Memorial and Associated Hospital, King Georges Medical University Shahmina Road Chowk Lucknow 226003
Lucknow
UTTAR PRADESH 
9839288980

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: I868||Varicose veins of other specifiedsites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparing two agents Ropivacaine (15mg) and fentanyl (20microgram)  Comparing two agents for varicose vein surgeries will evaluate their onset, duration, hemodynamic stability, side effects, and discharge readiness, ensuring optimal anesthetic management. 
Intervention  Ropivacaine, a local anesthetic with a sensory-motor block  Ropivacaine (15mg), a local anesthetic with a sensory-motor block , is used in ambulatory surgeries due to its fast recovery time. Its combination with fentanyl enhances anesthesia quality and postoperative pain relief. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients aged 18-80 years scheduled for day care varicose vein surgery.
Patients giving written informed consent will be taken
 
 
ExclusionCriteria 
Details  Patients with contraindications to spinal anesthesia or a history of opioid sensitivity.
Patients not giving consent will not be included in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
duration and quality of sensory and motor block, including time to achieve surgical anesthesia and time to complete recovery.  4 weeks to 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
intraoperative hemodynamic stability, postoperative analgesia duration, patient satisfaction, incidence of side effects such as pruritus, nausea, or respiratory depression, & readiness for discharge as per standard day care surgery criteria  4 weeks & 8 weeks 
 
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   N/A 
Date of First Enrollment (India)   10/09/2025 
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  

Day care varicose vein surgery is a critical surgical procedure that requires careful attention to anesthesia protocols to optimize patient comfort and safety. The selection between hyperbaric ropivacaine and its combination with fentanyl should align with the surgical goals and patient preferences, as patients often desire swift recovery and minimal postoperative complications. The comparison of equipotent doses of hyperbaric 0.75percent ropivacaine alone versus its combination with fentanyl stands out as a pivotal area of study. Ropivacaine is a newer amino-amide local anesthetic (LA) agent similar to bupivacaine in chemical structure but 30-40percent less potent. Intrathecal ropivacaine is a safe and effective option for spinal anesthesia due to its sensory-selective block and lower risk of motor blockade. The addition of fentanyl to this local anesthetic introduces the potential for synergistic effects, altering the pharmacodynamics of the anesthesia and potentially influencing recovery parameters. Understanding how these regimens compare is essential for optimizing anesthesia strategies and improving the overall surgical experience for patients undergoing day care varicose vein procedures. The choice between these two regimens requires careful consideration of multiple factors. Equipotent doses play a crucial role, as achieving comparable analgesia with a reduced total drug load may contribute to faster recovery and decreased side effects. Additionally, patient-specific characteristics, such as age, comorbidities, and pain sensitivity, influence the selection of the most suitable anesthesia protocol. The balance between effective pain control and minimizing adverse effects is paramount in the outpatient setting, where patients aim for a swift return to normal activities. This study addresses the gap in existing literature by providing a comprehensive examination of the comparative efficacy and safety of hyperbaric 0.75percent ropivacaine alone versus its combination with fentanyl in day care varicose vein surgery. Through an in-depth analysis of equipotent doses, patient outcomes, and anesthesia-related parameters, this research aims to contribute valuable insights that can inform evidence-based practices and enhance the quality of care in this specific surgical context. Gupta S et al (2024) evaluated the safety, efficacy, hemodynamic stability, and side effects of spinal anesthesia using 0.5percent hyperbaric bupivacaine and 0.75percent hyperbaric ropivacaine in patients undergoing transurethral resection of prostate. The study found that hyperbaric ropivacaine exhibited significantly slower onset times for sensory and motor blockade compared to hyperbaric bupivacaine. Patients in the ropivacaine group demonstrated better hemodynamic stability and experienced less hypotension compared to those who received bupivacaine. Moreover, the sensory and motor block lasted significantly longer in the bupivacaine group. About 0.75percent hyperbaric ropivacaine is a better choice for spinal anesthesia in elderly patients undergoing TURP as compared to 0.5percent hyperbaric bupivacaine.

AIMS AND OBJECTIVES

Aims:

·        To assess and compare the analgesic efficacy of hyperbaric 0.75percent ropivacaine alone and in combination with fentanyl in day care varicose vein surgery.

·        To evaluate recovery parameters, including time to ambulation and discharge, between the two anesthesia regimens.

 

Objectives:

·        To study the effect, onset, sensory effect, motor effects of both groups of patients

·        To analyze intraoperative parameters, such as sensory and motor blockade.

·        To investigate postoperative pain intensity and time to first analgesic request.

·        To assess the incidence of adverse effects, including nausea, vomiting, and pruritus.

·        To compare patient satisfaction and overall recovery experience with the two anesthesia approaches.

 

 

MATERIAL AND METHODS

 

Study Settings: The study will be conducted in Department of Anesthesiology, King George’s Medical University, Lucknow.

Study design:  Prospective randomized controlled study

Study duration: 2 years

Sample size:

Total 80 cases included in the study 40 in each group

 

Inclusion criteria:

·        Adult patients aged 18-80 years scheduled for day care varicose vein surgery.

·        Patients giving written informed consent will be taken

 Exclusion criteria:

·        Patients with contraindications to spinal anesthesia or a history of opioid sensitivity.

·        Patients not giving consent will not be included in the study.

 

STUDY PROTOCOL

Ethical clearance and Written and Informed consent will be taken. The study will be done at King George Medical University, Lucknow.   All randomly allocate participants into two groups:

 Group A Hyperbaric 0.75percent ropivacaine alone.

Group B  Hyperbaric 0.75percent ropivacaine with fentanyl.

Administer spinal anesthesia according to group allocation. Standardize the technique, including patient positioning, needle gauge, and injection speed. Record the exact dose administered in both groups.

All patients baseline characteristics: age, gender, BMI, and comorbidities. Monitor intraoperative parameters: blood pressure, heart rate, and oxygen saturation. Assess sensory and motor blockade using standardized scales at defined time intervals.  Record intraoperative adverse events or complications.

All patients evaluate postoperative pain using validated pain scales VAS to be measure. Document time to first request for analgesia. Monitor postoperative adverse effects, including nausea, vomiting, and pruritus. Conduct short-term follow-up to assess any delayed complications or adverse events.

Evaluate patient satisfaction with the anesthesia technique.

Statistical analysis

Statistical analysis was performed by the SPSS version 23rd version. Continuous variables were presented as mean SD and categorical variables were presented as absolute numbers and percentage. Normally distributed continuous variables and categorical variables were compared using appropriate statistical test. P value less than 0.05 was taken as significant.

 
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