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CTRI Number  CTRI/2024/06/069068 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 13/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study between two drugs in pediatric spinal anaesthesia 
Scientific Title of Study   Comparative study between intrathecal Bupivacaine heavy and intrathecal Ropivacaine heavy in pediatric patients undergoing lower limb or lower abdominal surgeries: A Prospective Randomized double blind 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  Dr Putul Kumari 
Designation  Post Graduate Student 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anesthesia, Neuro OT Complex, 1st Floor Ward Block,IGIMS,Sheikhpura, Patna, Bihar, India pin code-800014

Patna
BIHAR
800014
India 
Phone  8092216869  
Fax    
Email  drputulkumari@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bibha Kumari 
Designation  Additional Professor  
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anesthesia, Neuro OT Complex, 1st Floor Ward Block,IGIMS,Sheikhpura, Patna, Bihar, India pin code-800014

Patna
BIHAR
800014
India 
Phone  8252410069  
Fax    
Email  drbibha98aditi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bibha Kumari 
Designation  Additional Professor  
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anesthesia, Neuro OT Complex, 1st Floor Ward Block,IGIMS,Sheikhpura, Patna, Bihar, India pin code-800014

Patna
BIHAR
800014
India 
Phone  8252410069  
Fax    
Email  drbibha98aditi@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences, Department of Anesthesia, Neuro OT Complex, 1st Floor Ward Block, IGIMS, Sheikhpura, Patna, Bihar, India PIN CODE-800014. 
 
Primary Sponsor  
Name  Dr Putul Kumari 
Address  Department of Anesthesia, Neuro OT Complex, 1st Floor Ward Block,IGIMS,Sheikhpura, Patna, Bihar, India pin code-800014 
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 Putul Kumari  Indira Gandhi Institute of Medical Sciences, Patna, Bihar , India  Department of Anesthesia, Neuro OT Complex , 1st Floor Ward Block,IGIMS,Sheikhpura, Patna, Bihar, india pin code-800014
Patna
BIHAR 
8092216869

drputulkumari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences, Patna, Bihar , India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bupivacaine heavy (0.5%) and Fentanyl  intrathecal Bupivacaine with dose 0.5mg/kg body weight for less than 5kg, 0.4mg/kg body weight for 5-15 kg, 0.3mg/kg body weight for more than 15kg Intrathecal Fentanyl dose 0.2mcg/kg body weight for the duration for 6 hrs 
Intervention  Ropivacaine heavy (0.75%) and Fentanyl  intrathecal Ropivacaine with dose 1mg/kg body weight for less than 5kg, 0.5mg/kg body weight for 5-15 kg, 0.5mg/kg body weight for more than 15kg Intrathecal Fentanyl dose 0.2mcg/kg body weight for the duration 6hrs 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. parents of patients willing to participate
2. ASA garde 1-3
3. schedule for lower extremity or lower abdominal surgery
4. operative procedure requiring spinal anaesthesia 
 
ExclusionCriteria 
Details  1. Any contraindication to spinal anaesthesia(bleeding diathesis, infection at local site , congenital spinal anomaly )
2. patient with developmental delay
3. patient allergic to study drug 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To Compare the Blockade with Bupivacaine heavy and Ropivacaine heavy that is onset, level, degree and duration of block  In Operation Theatre(zero hours) 
 
Secondary Outcome  
Outcome  TimePoints 
To Monitor Hemodynamic Parameter(pulse, heart rate, systolic & diastolic blood pressure , mean arterial pressure)
side effect that is bradycardia, hypotension, vomiting, respiratory depression, itching, shivering
Post Operative Need of Additional Analgesia 
6 hrs 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 4 
Date of First Enrollment (India)   30/06/2024 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 30-06-2025 and end date provided 30-06-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

After obtaining written informed consent from parents of each patient, patients randomly allocated into 2 groups: group BF (0.5% Bupivacaine heavy with fentanyl,0.2 mcg/kg) and group RF (0.75%) Ropivacaine with Fentanyl,0.2mcg/kg) comprising 31 patients in each.  EMLA (enteric mixture of local anaesthetic) and occlusive dressing will be applied at the lumbar puncture site and venipuncture site one hour prior to surgery. Oral midazolam 0.5mg/kg with honey will be given to all patient 30 minute prior to surgery. Those patients who will not be cooperative sedation will be done by using injection ketamine 0.5 mg/kg body weight intravenously. Spinal anaesthesia will be given in L4-L5 space or L3-L4 space under all aseptic precautions with quincke cutting spinal needle 27G into two divided groups. Conventionally, SA is performed in a lateral decubitus position, with patient curled up and flexed at neck and hip joint. In paediatrics age group, care must be taken to avoid extreme neck flexion because of resultant upper airway obstruction leading to hypoxia. Both sitting and lateral positions have been found to be suitable. Depth of insertion at L4-5 varies with age (up to 5 years 15-25 mm, 5-8 years 30-40 mm). Distance from skin to subarachnoid space (mm) can be calculated by the formula {0.03 × height (cm)} or {2 × weight (kg) +7}.    Group BF will be given 0.5% Bupivacaine heavy in dose <5kg will be given 0.5-0.6mg/kg, 5-15 kg will be given 0.4 mg/kg, > 15kg will be 0.3mg/kg with fentanyl 0.2 mcg/kg.         Group RF will be given 0.75% Ropivacaine heavy in dose <5kg will be given 0.5-1mg/kg,   5-15 kg will be given 0.5mg/kg, >15kg will be given 0.5mg/kg with fentanyl 0.2mcg/kg.Caution will taken not to elevate lower extremity to avoid high or total SA.   Sensory and motor block will be assessed every 2minutes till complete   blockade. Parameters of observation

Sensory block assessment- With non traumatic in pin prick with 23G blunt   needle and facial expression or child movement will be observed.

Onset of sensory block- when patient feels dull sensation to prick or pinch   at T10 level

Time to complete sensory block –complete loss of sensation to prick or       pinch, temperature, touch and pain

Peak level- highest dermatome showing sensory blockade

Total duration of sensory block- Time interval between spinal drug injection and complete regression of sensory block upto lateral side of foot (S1). With subjective pain scale in children who express verbally and observational pain scale in children who could not express verbally

Motor block assessment- Motor blockade will be assessed by modified Bromage score

Postoperative HR, BP, SPO2 will be noted at every 3mins interval for 15mins, every 5mins for 30mins, then 15mins for 60mins, then 4hr, 6hr. Sensory and motor block will be assessed every 30 min after the surgery

Undesirable effects like nausea, vomiting, respiratory depression, pruritus, hypotension, and bradycardia will be noted. Study will be discontinued after 6hr or till complete recovery of sensory and motor function whichever is earlier.

Rescue analgesia by iv Paracetamol(15mg/kg).


 


 
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