| CTRI Number |
CTRI/2024/03/063448 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the postoperative pain control duration of transversus abdominis plane block and caudal block in children undergoing elective infra umbilical surgeries. |
|
Scientific Title of Study
|
A comparative study of transversus abdominis plane block versus caudal epidural block for postoperative analgesia in children undergoing elective infra umbilical 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 |
Vigneshwaran V |
| Designation |
Junior resident |
| Affiliation |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anaesthesiology
Guru Gobind Singh Medical College Hospital,
Faridkot,
Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
8248258709 |
| Fax |
|
| Email |
vickyn.vickyi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kewal Krishan Gupta |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anaesthesiology
Guru Gobind Singh Medical College Hospital,
Faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
9781812052 |
| Fax |
|
| Email |
doc_krishan31@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Kewal Krishan Gupta |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anaesthesiology
Guru Gobind Singh Medical College Hospital,
Faridkot.
Faridkot
PUNJAB
151203
India |
| Phone |
9781812052 |
| Fax |
|
| Email |
doc_krishan31@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,GGSMCH,Faridkot |
|
|
Primary Sponsor
|
| Name |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anaesthesiology,
Guru Gobind Singh Medical College Hospital,
Faridkot. |
| 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 Vigneshwaran V |
Guru Gobind Singh Medical College Hospital |
Department of Anaesthesiology,
Guru Gobind Singh Medical College Hospital,
Faridkot.
Faridkot
PUNJAB |
8248258709
vickyn.vickyi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Guru Gobind Singh Medical College |
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 |
| Intervention |
Caudal block |
To assess the post operative analgesic duration of caudal block using 0.25% levobupivacaine for 24 hours. |
| Comparator Agent |
Transversus abdominis plane block |
To assess the post operative analgesic duration of transversus abdominis plane block using 0.25% levobupivacaine for 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Pediatric patients aged 2 to 8 years belonging to ASA Grade I and II
2.Elective infra umbilical surgeries
|
|
| ExclusionCriteria |
| Details |
1.children undergoing bilateral infra umbilical surgeries.
2.children with altered sacral,caudal anatomy and skeletal deformities.
3. Local infection at the site of block
4.children with renal or hepatic insufficiency
5.known allergy to study drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time of first rescue analgesia from the time of caudal and TAP block |
Outcome will be assessed at the end of one and half year of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FLACC Scale score and intra operative hemodynamic variables |
Outcome will be assessed at the end of one and half year of study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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 Yet Recruiting |
| 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
|
Introduction : Lower abdominal surgeries are commonly performed in pediatric surgical units {for eg., Inguinal herniotomy, appendectomy, urethroplasty etc.,} and thesre are more commonly associated with post operative pain and discomfort. For effective pain control,Various analgesic modalities have been tried including low dose opioids, NSAIDs, local wound infiltration, neuraxial anesthesia and peripheral nerve blocks like ilioinguinal, iliohypogastric and Transversus abdominis plane block. Aim and objectives : To compare the post operative analgesic efficacy of Transversus Abdominis Plane block versus Caudal block in pediatric patients undergoing infra umbilical surgeries. The study will be conducted in a prospective, comparative and randomized manner in GGS medical college hospital, Faridkot on 60 children belonging to ASA grade I & II aged 2 to 8 years scheduled for infra umbilical surgeries under general anesthesia. The patients will be randomly allocated into two groups, Group T : will receive 1ml/kg of 0.25% levobupivacaine in USG guided TAP block. Group C: will receive 1ml/kg of 0.25% levobupivacaine in Caudal block . The patients will be observed post operatively for duration till first rescue analgesic requirement, total rescue analgesic consumption, pain score using FLACC pain score and any side effects and outcomes will be analyzed |