| CTRI Number |
CTRI/2018/03/012641 [Registered on: 19/03/2018] Trial Registered Prospectively |
| Last Modified On: |
16/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Regional anaesthesia for paediatric surgeriers |
|
Scientific Title of Study
|
Comparison of caudal anaesthesia and ilioinguinal block for paediatric inguinal surgeries and post operative analgesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Joginder Pal |
| Designation |
Professor |
| Affiliation |
Govt Medical College Amritsar |
| Address |
Department of Anaesthesia
Govt Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9501025275 |
| Fax |
|
| Email |
drjpattri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joginder Pal |
| Designation |
Professor |
| Affiliation |
Govt Medical College Amritsar |
| Address |
Department of Anaesthesia
Govt Medical College, Amritsar
PUNJAB
143001
India |
| Phone |
9501025275 |
| Fax |
|
| Email |
drjpattri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopvir Kaur |
| Designation |
Junior Resident |
| Affiliation |
Govt Medical College Amritsar |
| Address |
Department of Anaesthesia
Govt Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9478739044 |
| Fax |
|
| Email |
roopvirsaini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Medical College Amritsar |
|
|
Primary Sponsor
|
| Name |
Dr Joginder Pal |
| Address |
Department of Anaesthesia
Govt Medical College Amritsar |
| Type of Sponsor |
Other [Department of Ananesthesia] |
|
|
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 Joginder Pal |
Govt Medical College Amritsar |
Department of Anaesthesia
Amritsar
PUNJAB |
9501025275
drjpattri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA grade I and II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caudal versus ilioinguinal nerve block with same drugs |
Basically it is comparison between ilioinguinal nerve block and caudal nerve block |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children belonging to ASA group I/II
2. Age range between 3-12 years of either sex |
|
| ExclusionCriteria |
| Details |
1. Children belonging to ASA Grade 3 and 4
2. Children with history of coagulation disorders such as hemophilia, ITP, tumors or
DIC
3. Active infection at the site of injection such as cellulitis, abscess, meningitis etc.
4. Unstable BP or heart rate
5. Patient or parent refusal
6. Scoliosis
7. Congenital anomaly of spinal cord or vertebral bodies
8. Relatively contraindicated in patients with decreased cardiac function and in patients
with muscular dystrophy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Efficacy and quality of postoperative analgesia
2. Duration of postoperative analgesia |
12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications |
1-24 hours |
|
|
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 1 |
|
Date of First Enrollment (India)
|
19/03/2018 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a randomized prospective study which will be done to compare caudal anaesthesia and ilioinguinal block for paediatric inguinal surgeries and postoperative analgesia. The study will be carried out in 60 children of ASA grade I and II who will be divided into two groups of 30 each. Group A will be given caudal block, group B will be given illioinguinal/illiohypogastric block, both using combination of ropivacaine and dexmedetomidine. Both groups will be compared with respect to effect on efficacy and duration of postoperative analgesia and any complication if seen. The observations will be recorded on the proforma and the results will be statistically analysed in two groups. |