| CTRI Number |
CTRI/2025/07/091610 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of block characteristics of two local anesthetic agents when pregnant patients undergo caesarean section surgery under spinal anesthesia |
|
Scientific Title of Study
|
A randomized controlled trial comparing intrathecal hyperbaric Levobupivacaine 0.5 and hyperbaric Ropivacaine 0.75 for elective caesarean section : Analysis of block characteristics when an equipotent dose is used |
| 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 CHATTERJEE |
| Designation |
Senior consultant |
| Affiliation |
Tata Main Hospital |
| Address |
Department of Anaesthesiology, Main OT complex, 2nd floor, JGMH complex, Tata Main Hospital, Bistupur, Jamshedpur
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
7763807075 |
| Fax |
|
| Email |
dr.abhishek@tatasteel.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AYAN MAITI |
| Designation |
DNB resident |
| Affiliation |
Tata Main Hospital |
| Address |
Room no - 102
Block - B
TMH Doctors hostel
Dhatkidih, Kadma
Jamshedpur
Purbi Singhbhum
JHARKHAND
831005
India |
| Phone |
9830107264 |
| Fax |
|
| Email |
ayan.maiti89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ABHISHEK CHATTERJEE |
| Designation |
Senior consultant |
| Affiliation |
Tata Main Hospital |
| Address |
Department of Anaesthesiology,
Main OT complex, 2nd floor, JGMH block, Tata Main Hospital,
Bistupur
Jamshedpur
Purbi Singhbhum
JHARKHAND
831001
India |
| Phone |
7763807075 |
| Fax |
|
| Email |
dr.abhishek@tatasteel.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Main Hospital |
| Address |
BC road, Bistupur
Jamshedpur
Jharkhand - 831001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deb Sanjay Nag |
Tata Main Hospital |
Department of Anaesthesiology, Main OT, 2nd floor, JGMH block, Tata Main Hospital,
Bistupur
Jamshedpur
Jharkhand - 831001
Purbi Singhbhum
JHARKHAND |
7763807101
ds.nag@tatasteel.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Tata main Hospital, Jamshedpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levobupivacaine |
Levobupivacaine heavy 0.5%
Total duration 1 hour |
| Intervention |
Ropivacaine |
Ropivacaine heavy 0.75%
Total duration 1 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant females, 18 - 40 years age group, ASA 1 & 2, scheduled for elective caesarean section under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
History of allergy to local anesthetics
Uncontrolled systemic comorbid illness
Any obstetric complications
BMI > 30 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset, duration of sensory block
Onset, duration of motor block
Haemodynamic effects
|
Baseline
Immediately after spinal anesthesia
Every 2 minutes for 10 minutes
Every 5 minutes for next 10 minutes
Every 30 minutes till regression of sensory level to L5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Foetal effects
Postoperative analgesia
complications |
Every 30 minutes till regression of sensory level to L5 |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
05/08/2025 |
| 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="0"
Months="6"
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
|
We will be conducting a double blind randomized controlled study in which we will compare the motor and sensory blocks of two local anesthetic agents. We will include a total of 66 pregnant patients who will be scheduled for elective caesarean section under spinal anesthesia. We will observe the onset and duration of sensory as well as motor block characteristics along with hemodynamic effects and complications of both study drugs. |