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CTRI Number  CTRI/2025/09/094671 [Registered on: 12/09/2025] Trial Registered Prospectively
Last Modified On: 11/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing Two Types of Spinal Anesthesia (Bupivacaine vs Levobupivacaine) in Patients Undergoing Urological Surgeries 
Scientific Title of Study   COMPARISON OF 0.5% BUPIVACAINE AND 0.5% LEVOBUPIVACAINE UNDER SPINAL ANESTHESIA IN UROLOGICAL SURGERIES 
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 Abhijith A 
Designation  Resident 
Affiliation  Healthway Hospitals Pvt Ltd 
Address  OPD 2, Department of Anesthesia, First Floor, Healthway Hospitals Pvt Ltd, Plot No 132/1 (Part), Ella Village, Kadamba Plateau, Old Goa, Tiswadi - Goa

North Goa
GOA
403402
India 
Phone  6361028965  
Fax    
Email  dr.abhijithabhi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Pawar 
Designation  PG Guide 
Affiliation  Healthway Hospitals Pvt Ltd 
Address  OPD 2, Department of Anesthesia, First Floor, Healthway Hospitals Pvt Ltd, Plot No 132/1 (Part), Ella Village, Kadamba Plateau, Old Goa, Tiswadi - Goa

North Goa
GOA
403402
India 
Phone  9881054608  
Fax    
Email  drsandeeppawar7@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhijith A 
Designation  Resident 
Affiliation  Healthway Hospitals Pvt Ltd 
Address  OPD 2, Department of Anesthesia, First Floor, Healthway Hospitals Pvt Ltd, Plot No 132/1 (Part), Ella Village, Kadamba Plateau, Old Goa, Tiswadi - Goa

North Goa
GOA
403402
India 
Phone  6361028965  
Fax    
Email  dr.abhijithabhi@gmail.com  
 
Source of Monetary or Material Support  
Healthway Hospitals Pvt Ltd, Goa 
 
Primary Sponsor  
Name  Healthway Hospitals Pvt Ltd 
Address  Plot No 132/1 (Part), Ella Village, Kadamba Plateau, Old Goa, Tiswadi - Goa 
Type of Sponsor  Private hospital/clinic 
 
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 
Dr Abhijith A  HEALTHWAY HOSPITALS PVT. LTD.  OPD 2, Department of Anaesthesia, Plot No 132/1 (Part), Ella Village, Kadamba Plateau, Old Goa, Tiswadi - Goa
North Goa
GOA 
6361028965

dr.abhijithabhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Healthway Hospitals Goa  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.5% BUPIVACAINE  0.5% BUPIVACAINE 2.5mL WILL BE ADMINISTERED VIA 26G QUINCKE SPINAL NEEDLE AT LUMBAR INTRATHECAL SPACE 
Intervention  0.5% LEVOBUPIVACAINE  0.5% LEVOBUPIVACAINE 2.5mL WILL BE ADMINISTERED VIA 26G QUINCKE SPINAL NEEDLE AT LUMBAR INTRATHECALSPACE 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  -Patients aged between 18 and 75 years will be included.
-Only those with ASA (American Society of Anesthesiologists) physical status classification I or II (indicating healthy individuals or those with mild systemic disease) will be considered.
-Patients scheduled to undergo elective urological surgery under spinal anesthesia will be eligible.
-Written informed consent will be obtained from all participants.
 
 
ExclusionCriteria 
Details  Patients with a known allergy to amide local anesthetics will be excluded.
Individuals with severe cardiovascular, hepatic, renal, or neurological disorders will not be eligible.
Patients with contraindications to spinal anesthesia—such as spinal deformities, neurological disorders, or increased intracranial pressure—will be excluded.
Those with blood clotting disorders or currently on anticoagulant therapy will not be included.
Patients who refuse to participate in the study will be excluded.
Individuals with class II obesity (BMI MORE THAN EQUAL TO 30 kgm²) will be excluded.
Pregnant or lactating women will not be eligible to participate.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Time of onset of Sensory blockade
2. Time of onset of Motor blockade
3. Duration of sensory and motor block
4. Cardiovascular side effects associated with both the drugs
 
1. Time of onset of Sensory blockade- 5 hours
2. Time of onset of Motor blockade- 5 hours
3. Duration of sensory and motor block- 5 hours
4. Cardiovascular side effects associated with both the drugs- 5 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Cardiovascular side effects
2. Other post-operative complications 
5 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   22/09/2025 
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="2"
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  

Background:

Spinal anesthesia is a widely preferred technique for lower abdominal and urological surgeries due to its rapid onset and effective sensory and motor blockade. Among the commonly used agents for neuraxial blockade are bupivacaine and its S-enantiomer, levobupivacaine. While both are amide-type local anesthetics, levobupivacaine was developed to reduce the cardiotoxicity and neurotoxicity associated with racemic bupivacaine. Despite their widespread use, comparative data on the efficacy and safety of these procedures in urology remain limited.

Objective:

To compare the efficacy and safety of 0.5% hyperbaric bupivacaine versus 0.5% isobaric levobupivacaine in spinal anesthesia for patients undergoing elective urological surgeries.

Method:

This is a prospective, randomized clinical study. Patients scheduled for elective urological surgeries will be randomly assigned to receive either 0.5% hyperbaric bupivacaine or 0.5% hyperbaric levobupivacaine via spinal anesthesia. Parameters assessed will include onset time, peak block level, duration of sensory and motor blockade, intraoperative hemodynamic changes, and incidence of adverse effects. All clinical and safety parameters will be systematically recorded and analyzed.

Outcome:

The study will determine the comparative onset and duration of anesthesia, hemodynamic stability, incidence of side effects, and overall clinical efficacy of the two drugs in urological surgeries.



Significance:

By providing head-to-head data on bupivacaine and levobupivacaine in the specific context of urological procedures, this study aims to guide anesthetic drug selection, particularly for patients with cardiovascular risk factors or requiring tailored anesthetic plans. The findings could contribute to safer and more effective spinal anesthesia practices.


 
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