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CTRI Number  CTRI/2024/07/070609 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 13/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   the study will be conducted to compare the analgesic effects and block characteristics of intrathecal hyperbaric levobupivacaine and hyperbaric ropivacaine in elective caesarean sections. 
Scientific Title of Study   comparison of intrathecal hyperbaric levobupivacaine and hyperbaric ropivacaine in elective caesarean section: A randomized controlled double blinded 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  Surendra Kumar Jangid 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Dept of Anesthesia, 2nd Floor, All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Raebareli

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  8560919243  
Fax    
Email  dr.skjangid@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Surendra Kumar Jangid 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, raebareli 
Address  Dept of Anesthesia, 2nd Floor, All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Raebareli

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  8560919243  
Fax    
Email  dr.skjangid@gmail.com  
 
Details of Contact Person
Public Query  
Name  Surendra Kumar Jangid 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, raebareli 
Address  Dept of Anesthesia, 2nd Floor, All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Raebareli

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  8560919243  
Fax    
Email  dr.skjangid@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences,Munshiganj, Raebareli, Uttar Pradesh, India 229405 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Raebarel 
Address  All India Institute of Medical Sciences,munshiganj, Raebareli, Uttar pradesh, India 229405 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Surendra Kumar Jangid  All India Institute of Medical Sciences, Raebareli, Uttar Pradesh  Dept of Anesthesia and critical care, 2nd Floor, All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Raebareli
Rae Bareli
UTTAR PRADESH 		 8560919243

dr.skjangid@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BIOETHICS CELL, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAEBARELI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GROUP L 0.50% LEVOBUPIVACAINE  This group will receive 0.50% hyperbaric levobupivacaine 2ml (total dose 10mg) intrathecally (subarchnoid block). The occurrence of sensory block can be inferred when discriminating is lost in the T6 dermatome due to pinprick. The duration of the sensory block will thereafter be assessed with a two-segment regression analysis. The motor block will be evaluated using the adapted Bromage scale and The offset time will be considered as the corresponding restoration of normal motility. Hemodynamic parameters will be monitered and need for additional analgesics will be noted after observimg VAS score more than four. all the data will be monitored up to 24 hour postoperatively.  
Comparator Agent  GROUP R 0.75% ROPIVACAINE   This group will receive 0.75% hyperbaric ropivacaine 2ml (total dose 15 mg) intrathecally (subarchnoid block). The occurrence of sensory block can be inferred when discriminating is lost in the T6 dermatome due to pinprick. The duration of the sensory block will thereafter be assessed with a two-segment regression analysis. The motor block will be evaluated using the adapted Bromage scale and The offset time will be considered as the corresponding restoration of normal motility. Hemodynamic parameters will be monitered and need for additional analgesics will be noted after observimg VAS score more than four. all the data will be monitored up to 24 hour postoperatively.  
Intervention  INTRATHECAL BLOCK  Upon entering the operating room, standard monitoring devices including noninvasive blood pressure, pulse oximetry, electrocardiography, and temperature will be initiated. Additionally, oxygen at a rate of 4 litres per minute will be delivered through a face mask. An intravenous cannula will be placed into the non-dominant hand. A coloading procedure will be performed using Ringers lactated solution at a dosage of 10 ml per kilogramme of body weight. The initial assessment will involve recording the patients heart rate, systolic blood pressure, diastolic blood pressure, and mean blood pressure. Furthermore, the patient will be positioned in a seated posture. After the administration of local anaesthesia, a 25-gauge quincke point needle will be inserted into the L3-L4 interspace, and the medication will be intrathecally administered. After the administration of the subarachnoid block, patients will be placed in a supine position with a left lateral tilt. Surgery may commence once a sensory block of T6 or greater level has been attained. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Elective caesarean delivery, having a gestational age of more than 37 weeks,
2.ASA Class I or II.
3.BMI of 18-30
 
 
ExclusionCriteria 
Details  1.Refuse regional anaesthesia
2.Individuals with spinal deformity or known hypersensitivity to local anaesthetics
3.Those with placental or fetal abnormalities
4.Individuals with a body weight exceeding 100 kg,
5.Individuals with extreme heights (less than 150 cm or more than 180 cm)
6.Individuals with gestational or pregnancy-induced hypertension,
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To compare onset, regression and duration of sensory block between the groups
2.To compare onset, regression and duration of motor block between the groups
3.To compare duration of analgesisa between the groups 		 24hrs
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare hemodynamic effects between the groups  24 hrs 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2/ Phase 3 
Date of First Enrollment (India)   25/07/2024 
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 - NO
Brief Summary   This study is a randomized, double blind trial comparing efficacy of intrathecal hyperbaric levobupivacaine and hyperbaric ropivacaine in patients planned for elective caesarean section at AIIMS, Raebareli. The primary outcome is to compare onset, regression and duration of sensory and motor block and hemodynamic differences between the two groups. 
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