| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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.
|
|
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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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