| CTRI Number |
CTRI/2025/02/080915 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| 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 ACTION OF BUPIVACAINE 0.5 percent V/S LEVOBUPIVACAINE 0.5 percent IN SPINAL ANAESTHESIA FOR LOWER ABDOMINAL AND LOWER EXTERMITY SURGERIES |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF HYPERBARIC BUPIVACAINE 0.5 percent V/S HYPERBARIC LEVOBUPIVACAINE 0.5 percent IN SPINAL ANAESTHESIA FOR LOWER ABDOMINAL AND LOWER EXTERMITY 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 Sandhya singh |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9819865667 |
| Fax |
|
| Email |
1sandhyasingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Nath Shukla |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7080470075 |
| Fax |
|
| Email |
RICHANSHU45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garima Chaurasia |
| Designation |
Assistant Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9354134385 |
| Fax |
|
| Email |
Drgarima0011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital Lucknow road Banthara district
Shahjahanpur. Uttar Pradesh (India) Pin code- 242307 |
|
|
Primary Sponsor
|
| Name |
Dr sandhya singh |
| Address |
room no. 1004 department of anaesthesia first floor Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road, Banthara. |
| Type of Sponsor |
Other [self] |
|
|
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 sandhya singh |
Varun Arjun Medical College and Rohilkhand |
Department of Anaesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road Banthara
Shahjahanpur
UTTAR PRADESH |
9819865667
1sandhyasingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Varun Arjun Medical College & Rohilkhand Hospital NH24 Banthara shahjahanpur Uttar Pradesh 242307 India |
Approved |
|
|
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 |
hyperbaric bupivacaine 0.5% |
patient undergoing lower abdominal and lower extremity surgeries under spinal anesthesia using 0.3mg per kg hyperbaric bupivacaine will be done or 1year |
| Comparator Agent |
hyperbaric levobupivacaine 0.5% |
patient undergoing lower abdominal and lower extremity surgeries under spinal anesthesia using 0.3mg per kg hyperbaric levobupivacaine will be done or 1year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of Anaesthesiologist (ASA) physical status I/II
Planned for elective surgery under Spinal anaesthesia.
BMI -18.5-25
|
|
| ExclusionCriteria |
| Details |
Patients refusing consent
Patients having local sepsis at site where spinal anesthesia is to given.
Patients with known bleeding or coagulation disorders
Patients with spinal deformity
Patients with Cardiopulmonary diseases
Patients with Neurological or psychiatric disorders.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To explore the dose-response relationship
between hyperbaric
bupivacaine and hyperbaric levobupivaciane regarding anaesthesia quality and
duration |
Every 3 min for 15 min then every 15 min till
recovery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify any potential predictors of optimal
dose selection based on
individual patient factors & surgical requirements |
Every 3 min for 15 min then every 15 min till
recovery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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 Applicable |
| 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
|
Spinal anesthesia is a widely used technique for regional anesthesia, offering advantages such as rapid onset, patient wakefulness, minimal side effects, and reduced need for airway manipulation. It is especially preferred for lower abdominal and lower extremity surgeries due to its effective sensory and motor blockade, quick action, and lower risk of complications like thromboembolic events. Bupivacaine, a commonly used anesthetic, has both dextro- and levo-isomers. The dextro-isomer is associated with higher cardiotoxicity, prompting the development of levobupivacaine (the S-isomer), which has lower cardiovascular and CNS toxicity while maintaining similar analgesic efficacy. Levobupivacaine tends to produce a more prolonged sensory and motor blockade compared to racemic bupivacaine. This study aims to compare the effects of hyperbaric bupivacaine 0.5% versus hyperbaric levobupivacaine 0.5% in spinal anesthesia for lower abdominal and lower extremity surgeries. |