| CTRI Number |
CTRI/2024/10/074744 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Duration of Analgesia in Ultrasound Guided Transverse abdominal plane Block and Ultrasound guided Caudal block in Paediatric patients in postoperative period |
|
Scientific Title of Study
|
To compare the analgesic efficacy and duration of analgesia in ultrasound guided TAP block vs ultrasound guided CAUDAL block in paediatric patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEPAK KUMAR |
| Designation |
Junior Resident 3 |
| Affiliation |
GSVM Medical College |
| Address |
Department of Anaesthesia
L.L.R.H and
GSVM Medical College
Swaroop Nagar Kanpur 208002
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
07897489512 |
| Fax |
|
| Email |
deepakmaf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
CHANDRASHEKHAR SINGH |
| Designation |
PROFESSOR |
| Affiliation |
GSVM Medical College |
| Address |
Department of Anaesthesia
L.L.R.H. and
GSVM Medical College
Swaroop Nagar Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9236072730 |
| Fax |
|
| Email |
chandrashekhar77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DEEPAK KUMAR |
| Designation |
Junior Resident 3 |
| Affiliation |
GSVM Medical College |
| Address |
Department of Anaesthesia
L.L.R.H. and
GSVM Medical College
Swaroop Nagar 208002
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
07897489512 |
| Fax |
|
| Email |
deepakmaf@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIA
L.L.R.H. and GSVM Medical College
Kanpur 208002 |
|
|
Primary Sponsor
|
| Name |
DEEPAK KUMAR |
| Address |
Department of Anesthesia
GSVM MEDICAL COLLEGE |
| Type of Sponsor |
Other [Self funded] |
|
|
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 DEEPAK KUMAR |
L.L.R. Hospital and G.S.V.M. Medical College |
Department of Anesthesia, General Surgery Operation Theatre 1,2&3
Kanpur Nagar
UTTAR PRADESH |
07897489512
deepakmaf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethics Committee, GSVM Medical College |
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 |
| Intervention |
Ultrasound Guided Caudal Block |
0.5ml/kg of 0.25% isobaric bupivacaine is used as drug for giving caudal block as single dose using linear ultrasound probe using in plane technique, given just before the extubating patient from General Anesthesia |
| Intervention |
Ultrasound Guided Transverse Abdominal Plane Block |
0.5ml/kg of 0.25% isobaric bupivacaine is used as drug for giving Transverse Abdominal Plane Block as single dose using linear ultrasound probe using in plane technique, given just before the extubating patient from General Anesthesia |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Informed written consent for participation in study
Age more than 5 years and less than 12 years
ASA grade 1 and 2
|
|
| ExclusionCriteria |
| Details |
Consent not given
Age less than 5 years or more than 12 years
ASA grade 3 and 4
Blood coagulopathies, local site infection, allergy to drug.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the duration of post operative rescue analgesic free analgesia |
0hr, 2hr,4hr,6hr,8hr,12hr,18hr,24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the rescue analgesic dose requirement in post operative period |
At 1 hour, 2hour, 4hour, 6hour,8hour,12hour, 18hour |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
15/10/2024 |
| 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
|
Aim Aim of this study is to compare the duration of post operative analgesia between USG guided TAP block and USG guided caudal block in paediatric patients undergoing unilateral below umbilical surgeries. Setting This study is conducted in the Department of Anaesthesiology and Critical Care Medicine in GSVM medical college, Kanpur, Uttar Pradesh. Design This study is a prospective, randomized and comparative study. Materials and Methods Total 42 patients were included in this study of ASA grade I & II, age ranging from 5-12 years, planned for unilateral below umbilical surgeries were randomized into two groups of 21 patients each group. Exclusion criteria include lack of consent by the parents, local site infection, any vertebral deformity, coagulopathies and previous known history of allergy. Tap Group: received TAP block with 0.5mL/kg of 0.25% bupivacaine under USG guidance. Caudal Group: received caudal block under USG guidance with 0.5mL/kg of 0.25% bupivacaine, with patient in left lateral position. Place of work: The proposed study is carried out in the Department of Anesthesiology, GSVM Medical College, and Associate LLRH Hospital. |