| 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
|
|
|
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
|
|
|
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
|
|
|
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. |