| CTRI Number |
CTRI/2026/04/109244 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
22/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study in 80 Pregnant Women Undergoing Planned Cesarean Section Comparing Two Spinal Anaesthesia Drugs Levobupivacaine and Bupivacaine for Safety and Effectiveness
|
|
Scientific Title of Study
|
Efficacy and safety of hyperbaric levobupivacaine vs. hyperbaric bupivacaine in spinal anaesthesia for caesarean section |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maansi Kolle |
| Designation |
Junior Resident |
| Affiliation |
K S HEGDE MEDICAL ACADEMY |
| Address |
Department of Anaesthesiology and Critical Care, K S Hegde Academy, P O Nithyanandagar, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9640431680 |
| Fax |
|
| Email |
maansikolle77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RASHMI SOORI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
K S HEGDE MEDICAL ACADEMY |
| Address |
Department of Anaesthesiology and Critical Care, K S Hegde Academy, P O Nithyanandagar, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8050152374 |
| Fax |
|
| Email |
drrashmisoori@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RASHMI SOORI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
K S HEGDE MEDICAL ACADEMY |
| Address |
Department of Anaesthesiology and Critical Care, K S Hegde Academy, P O Nithyanandagar, Mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8050152374 |
| Fax |
|
| Email |
drrashmisoori@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology and Critical care, K S Hegde Medical Academy, P.O Nithyanandagar, Mangalore
Dakshina Kannada, Karnataka
575018, India |
| 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 |
| DR MAANSI KOLLE |
K S HEGDE MEDICAL ACADEMY |
Department of Anaesthesiology and Critical Care, P O Nithyanandagar, Mangalore, Karnataka, 575018
Dakshina Kannada
KARNATAKA |
9640431680
maansikolle77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE, K S HEGDE MEDICAL ACADEMY |
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 |
| Comparator Agent |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant ladies aged above 18 years undergoing lower segment caeserean section under spinal anaesthesia using 25G Quincke Babcock needle
2.ASA physical status II
3.Singleton pregnancy
4.Height of 150 cm or more |
|
| ExclusionCriteria |
| Details |
1.History of allergy to study drugs
2.Pregnant females with neurological deficits of lower extremities
3.Complicated pregnancy
4.Conversion of spinal to general anaesthesia intraoperatively
5.Duration more than 2hours
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the efficacy in terms of onset and duration of motor and sensory block in every 1 min until 5 min followed by every 5 min between the hyperbaric Levobupivacaine with Fentanyl versus hyperbaric Bupivacaine with Fentanyl in spinal anaesthesia for elective caesarean sections
2.To compare the safety in terms of hemodynamic profile of hyperbaric Levobupivacaine with Fentanyl versus hyperbaric Bupivacaine with Fentanyl in spinal anaesthesia for elective caesarean sections |
1.To compare the efficacy in terms of onset and duration of motor and sensory block 1 min until 5 min followed by every 5 min between the hyperbaric Levobupivacaine with Fentanyl versus hyperbaric Bupivacaine with Fentanyl in spinal anaesthesia for elective caesarean sections
2.To compare the safety in terms of hemodynamic profile of hyperbaric Levobupivacaine with Fentanyl versus hyperbaric Bupivacaine with Fentanyl in spinal anaesthesia for elective caesarean sections |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the adverse effects during the surgery
2.To compare the APGAR scores of neonate born to mothers at 1 min after birth & 5 min after birth
3.To evaluate the time to first rescue analgesic administration within 24 hours postoperatively
4.To compare the satisfaction of operating surgeon immediately post surgery |
1.To compare the adverse effects during the surgery
2.To compare the APGAR scores of neonate born to mothers at 1 min after birth & 5 min after birth
3.To evaluate the time to first rescue analgesic administration within 24 hours postoperatively
4.To compare the satisfaction of operating surgeon immediately post surgery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
03/05/2026 |
| 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 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
|
This randomized controlled observational study compares the efficacy and safety of hyperbaric levobupivacaine with fentanyl versus hyperbaric bupivacaine with fentanyl for spinal anaesthesia in elective caesarean sections.The primary objective is to evaluate the onset and duration of sensory and motor block and comparison of maternal hemodynamic parameters. Pregnant women over 18 years undergoing elective caesarean delivery will be randomly allocated to either group. |