| CTRI Number |
CTRI/2025/11/097259 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia
Screening
Other (Specify) [Transthoracic echo] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of two spinal anaesthesia injections called levobupivacaine and bupivacaine, on output of heart in caesarean section patients. |
|
Scientific Title of Study
|
Effect of Hyperbaric Levobupivacaine and Bupivacaine on Realtime Cardiac index during Spinal Anesthesia for Cesarean Section A Randomized Control 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 |
BASKAR C |
| Designation |
POST GRADUATE |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
POST GRADUATE
DEPARTMENT OF ANAESTHESIOLOGY
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PONDICHERRY
POST GRADUATE
DEPARTMENT OF ANAESTHESIOLOGY
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PONDICHERRY
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9894373947 |
| Fax |
|
| Email |
dr.baskar87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RANI P |
| Designation |
PROFESSOR |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PONDICHERRY
DEPARTMENT OF ANAESTHESIOLOGY
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PONDICHERRY
Pondicherry
PONDICHERRY
607403
India |
| Phone |
6381405201 |
| Fax |
|
| Email |
anaesrani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RANI P |
| Designation |
PROFESSOR |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PONDICHERRY
DEPARTMENT OF ANAESTHESIOLOGY
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PONDICHERRY
Pondicherry
PONDICHERRY
607403
India |
| Phone |
6381405201 |
| Fax |
|
| Email |
anaesrani@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute , Pondicherry - Cuddalore Rd, ECR, Pillayarkuppam, Puducherry 607403 |
| Type of Sponsor |
Private 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 |
| HEMANTH KUMAR V |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTION |
DEPARTMENT OF ANAESTHESIOLOGY
PONDICHERRYT
Pondicherry
PONDICHERRY |
9003550553
anaesthesiology@mgmcri.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Spina anesthesia |
The study involves administration of 2 ml of 0.5% hyperbaric Bupivacaine as a single-shot spinal anesthesia for cesarean section.
Dose: 2 ml of 0.5% hyperbaric Bupivacaine
Frequency: Single administration (single-shot spinal block)
Total duration: One-time administration for intraoperative anesthesia during cesarean delivery (approximately 60–90 minutes)
Route: Intrathecal (subarachnoid block at L3–L4 or L4–L5 interspace)
|
| Intervention |
Spinal Anaesthesia |
The study involves administration of 2 ml of 0.5% hyperbaric Levobupivacaine as a single-shot spinal anesthesia for cesarean section.
Dose: 2 ml of 0.5% hyperbaric Levobupivacaine
Frequency: Single administration (single-shot spinal block)
Total duration: One-time administration for intraoperative anesthesia during cesarean delivery (approximately 60–90 minutes)
Route: Intrathecal (subarachnoid block at L3–L4 or L4–L5 interspace)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Singleton uncomplicated pregnancy
2. Willing Patients
|
|
| ExclusionCriteria |
| Details |
1. Hypertensive disorders of pregnancy, severe valvular stenotic lesions, Deep vein thrombosis
2. Hypersensitivity to Local anesthetics
3. Anemia in Pregnancy
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the cardiac index between 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric Bupivacaine during spinal anesthesia for cesarean section, measured using Transthoracic Echocardiography (TTE) at predefined time points
|
T0: Baseline (before spinal anesthesia)
T1: Post-spinal (after achieving T4 sensory level)
T2: Post-delivery.
Change in cardiac index (L/min/m²) between the two groups at these time intervals. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic parameters
Changes in mean arterial pressure (MAP), systolic and diastolic blood pressure, and heart rate at predefined time points.
2. Systemic vascular resistance surrogate
Doppler Resistive Index of the descending thoracic aorta (before spinal anaesthesia, post-spinal, and post-delivery).
3. Vasopressor requirement
Total number and dose of vasopressor boluses required intraoperatively.
4. Duration and quality of analgesia
Time to first request for postoperative analgesia.
5. Adverse effects
Incidence of hypotension, bradycardia, nausea, vomiting, pruritus, and shivering.
|
1. Real-time echocardiographic cardiac index measurement: Unlike previous studies that used pulse contour or indirect methods, our study uses transthoracic echocardiography (TTE), giving direct, objective, and accurate assessment of cardiac function.
2. Novel parameter – Resistive Index of Descending Thoracic Aorta: This serves as a surrogate for systemic vascular resistance, adding new physiological insights into maternal hemodynamic under spinal anaesthesia.
3. Clinical relevance: By directly correlating cardiac index changes with drug choice, the study could influence drug selection protocols for obstetric anaesthesia, potentially improving maternal safety.
4. Safety profile: Levobupivacaine, being the S (-) enantiomer, has lower cardiotoxicity and neurotoxicity than racemic bupivacaine, which supports its use in vulnerable populations like parturients.
5. Contribution to Indian data: Limited Indian studies have focused on real-time CI changes in caesarean section spinal anaesthesia, so our work will add valuable regional evidence
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - To gain access, data requestors will need to sign a data access agreement.Proposals should be directed to primary investigators email- dr.baskar87@gmail.com
- For how long will this data be available start date provided 10-07-2027 and end date provided 09-07-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective randomized controlled study is designed to compare the effects of 0.5% hyperbaric levobupivacaine and hyperbaric bupivacaine on maternal hemodynamic during spinal anaesthesia for elective caesarean section the primary focus is on real time cardiac index measure using transthoracic echocardiography along with assessment of mean arterial pressure systemic vascular resistance vasopressor requirements and side effects Spinal anaesthesia though a preferred for caesarean sections is often complicated by maternal hypotension and reduced cardiac output levobupivacaine the s enantiomer of bupivacaine offers a safer pharmacological profile with reduced cardiotoxicity and better hemodynamic stability this study aims to objectively quantify these differences using echocardiographic parameters providing more accurate insights than earlier studies that used indirect monitoring It is hypothesized that levobupivacaine will better preserve cardiac index and came less hypotension compared to bupivacaine to bupivacaine thereby reducing vasopressor use and improving maternal safety Findings from this trial may help optimize anesthetic drug selection in obstetric practice ensuring safer perioperative management for mothers and neonates |