| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- 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.
- 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).
|