FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/088138 [Registered on: 03/06/2025] Trial Registered Prospectively
Last Modified On: 02/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Spinal anesthesia in neonates and infants 
Scientific Title of Study   A randomized, double blind, superiority trial comparing hyperbaric bupivacaine and hyperbaric ropivacaine in neonates and infants undergoing infraumbilical surgeries. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhuvaneshwari Balasubramanian 
Designation  Associate Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES , NAGPUR 
Address  Department of Anesthesia, 1st Floor OT Complex, IPD building , AIIMS Nagpur, MIHAN, Nagpur.

Nagpur
MAHARASHTRA
441108
India 
Phone  7021449685  
Fax    
Email  docbhuvaneshwari@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sucheta Gore 
Designation  Junior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES , NAGPUR 
Address  Department of Anesthesia, 1st Floor OT Complex, IPD building , AIIMS Nagpur, MIHAN, Nagpur.

Nagpur
MAHARASHTRA
441108
India 
Phone  8237838067  
Fax    
Email  varadagore1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhuvaneshwari Balasubramanian 
Designation  Associate Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES , NAGPUR 
Address  Department of Anesthesia, 1st Floor OT Complex, IPD building , AIIMS Nagpur, MIHAN, Nagpur.

Nagpur
MAHARASHTRA
441108
India 
Phone  7021449685  
Fax    
Email  docbhuvaneshwari@gmail.com  
 
Source of Monetary or Material Support  
SELF 
 
Primary Sponsor  
Name  Sucheta Gore 
Address  Department of Anesthesia, IPD OT complex, 1st floor, IPD building, AIIMS Nagpur, MIHAN 
Type of Sponsor  Other [Self] 
 
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 
Dr Bhuvaneshwari B  AIIMS Nagpur  Department of Anaesthesia,IPD OPD complex,1st floor IPD Building . MIHAN Nagpur 441108 India
Nagpur
MAHARASHTRA 
7021449685

docbhuvaneshwari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  hyperbaric bupivacaine  local anesthetic agent hyperbaric bupivacaine 0.5% will be given intrathecally. Dose= 0.5mg/kg. Intervention duration= 5-10 mins 
Intervention  hyperbaric ropivacaine  Local anesthetic agent hyperbaric ropivacaine 0.5% will be given intrathecally. Dose= 0.5mg/kg. Intervention duration5-10 minutes 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  1.00 Year(s)
Gender  Both 
Details  Parents willing to enroll their children in this study.
Age less than or equal to 1 year.
Patients undergoing infraumbilical surgeries.
ASA grade 1 & 2 
 
ExclusionCriteria 
Details  Parents not consenting for the procedure.
Patients having increased intracranial pressure.
Patients having allergy to local anesthetic drugs.
Patients having local site infection.
Uncorrected hypovolaemia.
Coagulation abnormalities.
Neurological abnormalities such as spina bifida, meningocele.
Patients already on mechanical ventilation.

 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be assessing the effectiveness of the anaesthesic drug by comparing the block parameters such as onset, duration  1,5,10,15,20,30,45,60,90 mins 
 
Secondary Outcome  
Outcome  TimePoints 
Heamodynamic stability: assessing the heart rate , blood pressure, oxygen saturation throughout the procedure.
Requirement of rescue analgesia and conversion to GA or mechanical ventilation.
Surgeon satisfaction with the depth of anesthesia.
 
1,5,10,15,20,30,45,60,90 mins for hemodynamic parameters 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   16/06/2025 
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="1"
Months="6"
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  

Spinal anesthesia, also called subarachnoid block, is increasingly used for infraumbilical surgeries in infants and children. The spinal cord in infants ends lower than in adults, making specific techniques necessary to avoid injury. This method provides advantages such as reduced incidence of hypotension, hypoxia, bradycardia, and postoperative apnea, compared to general anesthesia (GA), which enhances cardiovascular and respiratory stability. After surgery, early mobilization, hydration, and proper pain management are essential.

Hyperbaric bupivacaine and ropivacaine, amide local anesthetics, are commonly used in spinal anesthesia. Bupivacaine is highly potent but associated with higher risks of hypotension and bradycardia, while ropivacaine has a lower cardiotoxicity and is favored for sensory-motor differential blockade. Both anesthetics are effective, though bupivacaine offers faster and denser blocks, while ropivacaine allows earlier ambulation and recovery.

This study aims to compare the efficacy of 0.5% hyperbaric bupivacaine versus 0.5% hyperbaric ropivacaine in infants undergoing infraumbilical surgeries. Primary objectives include comparing neuronal blockade (motor and sensory), while secondary objectives include assessing hemodynamic stability, post-operative apnea, analgesia needs, and surgeon satisfaction.

A double-blind randomized controlled trial will be conducted at AIIMS Nagpur. Patients under 1 year of age undergoing infraumbilical surgeries will be included, with those meeting exclusion criteria such as neurological abnormalities or surgery duration over 90 minutes being excluded. Each group will receive either hyperbaric bupivacaine or ropivacaine, and various anesthetic parameters will be monitored, including onset time, duration of blockade, and postoperative complications. Data analysis will involve statistical methods such as the independent T-test and chi-square test for comparison.

This research aims to assess the safety and efficacy of these anesthetics, contributing to better understanding and decision-making for pediatric spinal anesthesia.

 
Close