| CTRI Number |
CTRI/2026/01/101801 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
compare sensory and motor block of two different drugs in elective caesarean section |
|
Scientific Title of Study
|
Comparative Study of the Characteristics of Sensory and Motor Block Duration of Analgesia Between Intrathecal Hyperbaric Ropivacaine (0.75%) and hyperbaric levobupivacaine (0.5%) Along with 2mg Nalbuphine as an Adjuvant in Patients Undergoing Elective Caesarean Section: A Randomized Controlled 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 |
Priyanka patel |
| Designation |
3rd year resident |
| Affiliation |
GMERS MEDICAL COLLEGE GOTRI VADODARA |
| Address |
Parishram nivas koliwad rabdi post-panchalai killa pardi Dist-valsad-396125
Vadodara
GUJARAT
396125
India |
| Phone |
9558565787 |
| Fax |
|
| Email |
drpriyankapatel25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishal shrimali |
| Designation |
Associate professor |
| Affiliation |
GMERS MEDICAL COLLEGE GOTRI VADODARA |
| Address |
C-101 A aditya aspire vasana-bhayali road vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825792920 |
| Fax |
|
| Email |
dr.vishalshrimali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishal shrimali |
| Designation |
Associate professor |
| Affiliation |
GMERS MEDICAL COLLEGE GOTRI VADODARA |
| Address |
C-101 A aditya aspire vasana-bhayali road vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
9825792920 |
| Fax |
|
| Email |
dr.vishalshrimali@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical College and hospital Gotri Vadodara |
|
|
Primary Sponsor
|
| Name |
GMERS HOSPITAL |
| Address |
Old TB Hospital campus,Gotri main Road,gotri ,Vadodara-390001,Gujarat,India |
| Type of Sponsor |
Government 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 |
| Priyanka Ishverbhai patel |
GMERS Hospital,Gotri,vadodara |
6th floor,Department of Anaesthesiology,GMERS Medical College,gotri,vadodara,GUJARAT
Vadodara
GUJARAT |
9558565787
drpriyankapatel25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC,GMERS MEDICAL COLLEGE AND HOSPITAL,GOTRI,VADODARA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group L (levobupivacaine) |
under all aseptic and antiseptic precautions patient placed in sitting position subarachnoid block with 23G quincke spinal needle in L2-L3 OR L3-L4 interspace with midline approach 1.8 ml 0.5% hyperbaric levobupivacaine+ 0.2 MG Nalbuphine will be injected after the free flow of csf fluid
|
| Intervention |
Group R (Ropivacaine) |
under all aseptic and antiseptic precautions patient placed in sitting position subarachnoid block with 23G quincke spinal needle in L2-L3 OR L3-L4 interspace with midline approach 1.8 ml 0.75% hyperbaric ropivacaine+ 0.2 MG Nalbuphine will be injected after the free flow of csf fluid |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA Physical status 2 and 3
Weight - 40 kg to 85 kg |
|
| ExclusionCriteria |
| Details |
Short stature (Ht -150 cm)
Patient refusal
Patient with allergy to local anesthetics drugs
Pre-existing or pregnancy-induced HTN Preeclampsia cardiovascular cerebral diseases
Placenta previa placenta abruption
Foetal distress or foetal abnormalities
Multiple gestations |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Difference of onset of sensory and motor block of intrathecal 1.8 ml hyperbaric ropivacaine(0.75%) verse 1.8
ml hyperbaric levobupivacaine(0.5%) with 2 mg nalbuphine as an adjuvant |
Difference of onset of sensory and motor block of intrathecal 1.8 ml hyperbaric ropivacaine(0.75%) verse 1.8
ml hyperbaric levobupivacaine(0.5%) with 2 mg nalbuphine as an adjuvant |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
pulse,mean arterial pressure,oxygen saturation
Duration of post-operative analgesia
complication(nausea,vomiting,
bradycardia,hypotension,shivering
|
Baseline hemodynamic parameters (before spinal anesthesia)
every 2 min fir 1st 10 min after intrathecal injection
From time of intrathecal drug administration to 1st request for rescue analgesia VAS more than 4
advers effects assessed intraoperatively and 24 hrs postoperatively |
|
|
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)
|
01/02/2026 |
| 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="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
|
This study is a prospective, randomized, double-blind controlled clinical trial designed to compare the characteristics of sensory and motor block produced by intrathecal hyperbaric ropivacaine (0.75%) and hyperbaric levobupivacaine (0.5%), both combined with 2 mg nalbuphine as an adjuvant, in patients undergoing elective caesarean section. A total of 30 ASA II–III parturients aged 18–40 years scheduled for elective caesarean section under spinal anaesthesia will be enrolled and randomly allocated into two equal groups. Group R will receive 1.8 ml hyperbaric ropivacaine (0.75%) with 2 mg nalbuphine, while Group L will receive 1.8 ml hyperbaric levobupivacaine (0.5%) with 2 mg nalbuphine. The primary outcome is to compare the onset of sensory and motor block between the two groups. Secondary outcomes include duration of postoperative analgesia, two-segment sensory regression time, intraoperative hemodynamic changes, and incidence of adverse effects such as hypotension, bradycardia, nausea, vomiting, pruritus, shivering, and respiratory depression. The study aims to identify an intrathecal drug combination that provides effective anaesthesia, stable maternal hemodynamics, adequate postoperative analgesia, and early recovery in patients undergoing elective caesarean section |