| CTRI Number |
CTRI/2024/09/073623 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between transversus abdominal plane block and caudal block in children for post operative pain relief. |
|
Scientific Title of Study
|
Ultra sound guided transversus abdominis plane block versus ultra sound guided caudal block for post operative analgesia in paediatric patient undergoing lower abdominal surgery; a comparative 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 Subhadeep Pramanik |
| Designation |
Post graduate trainee anesthesiology |
| Affiliation |
Institute of post graduate medical education and research |
| Address |
Institute of post graduate medical education and research
Department of anesthesiology
244 AJC bose road kolkata 700020
kolkata
west bengal
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9674295231 |
| Fax |
|
| Email |
subhadeeppramanik1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohanchandra Mandal |
| Designation |
Professor Department of anesthesiology |
| Affiliation |
Institute of post graduate medical education and research |
| Address |
Institute of post graduate medical education and research
Department of anesthesiology
244 AJC bose road kolkata 700020
kolkata
west bengal
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433072820 |
| Fax |
|
| Email |
drmcmandal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangita Mandal |
| Designation |
Assisstant professor |
| Affiliation |
Institute of post graduate medical education and research |
| Address |
Institute of post graduate medical education and research
Department of anesthesiology
244 AJC bose road kolkata 700020
kolkata
west bengal
India
Kolkata
WEST BENGAL
700020
India |
| Phone |
7980735443 |
| Fax |
|
| Email |
sangitamandal1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology
Institute of post graduate medical education and research,
kolkata 700020,India |
|
|
Primary Sponsor
|
| Name |
Department of anesthesiology |
| Address |
Institute of post graduate medical education and research
244 AJC Bose road , kolkata 700020, West Bengal
kolkata 700020 |
| Type of Sponsor |
Government medical college |
|
|
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 subhadeep pramanik |
Institute of post graduate medical education and research |
Third floor, paediatric surgery operation theatre( room number 3),main block, department of anaesthesiology,
244 AJC Bose road, kolkata 700020, West bengal.
Kolkata
WEST BENGAL |
9674295231
subhadeeppramanik1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
local anaesthetic drug bupivacaine will be used to give USG-guided caudal block |
Passage of 22-gauge needle through the sacral hiatus will be observed, bupivacaine 0.25% will be administered at dose of 1 ml/kg following negative aspiration of blood and CSF. Pain will be assessed at 2,4,6,8,12 and 24 hours after surgery using FLACC scale. If pain score using FLACC scale becomes higher than 3, injection paracetamol will be administered at dose of 15 mg/kg through IV route. Total consumption of paracetamol in the first 24 hours will be recorded. |
| Intervention |
local anaesthetic drug bupivacaine will be used to give USG-guided transversus abdominis plane block |
on entering the transversus abdominis plane, a total of 0.5 ml/kg, 0.25% of bupivcaine will be administered.Pain will be assessed at 2,4,6,8,12 and 24 hours after surgery using FLACC scale. If pain score using FLACC scale becomes higher than 3, injection paracetamol will be administered at dose of 15 mg/kg through IV route. Total consumption of paracetamol in the first 24 hours will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
asa physical status I and II
aged between 1 year and 7 year
patients undergoing lower abdominal surgeries |
|
| ExclusionCriteria |
| Details |
refusal to consent
known coagulopathy
skin infection
evidence of peritonitis
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of post operative analgesia that is defined as the time interval between administration of nerve block and requirement of the first rescue analgesia( paracetamol) in the post operative period |
first 24 hours in the postoperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
total consumption of paracetamol in the first 24 hours of postoperative period
|
first 24 hours of postoperative period |
| parents satisfaction |
first 24 hours of post operative period |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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 3 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| 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 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
|
post operative analgesia is an upcoming concept in the anaesthesia specially being used in case of paediatrics patients. Post operative analgesia increases the chances of early recovery , better prognosis and hence early discharge from the hospital. In this study, two methods of post operatiove analgesia will be used , one being USG guided transversus abdominis plane block other being USG guided caudal block. Then comparison will be made between them regarding the duration of postoperative analgesia achieved and requirement of analgesic in the first 24 hours of post operative period. |