| CTRI Number |
CTRI/2016/02/006688 [Registered on: 26/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of caudal epidural block with paravertebral block for renal surgeries in paediatric patients |
|
Scientific Title of Study
|
Comparison of caudal epidural block with paravertebral block for renal surgeries in paediatric patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Purnima N |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Junior Resident, Department of Anaesthesiology, Pain Medicine and Critical Care,All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
purni89@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Lokesh Kashyap |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
lokeshkashyap@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Lokesh Kashyap |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
lokeshkashyap@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi- 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar East, New Delhi- 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Purnima N |
All India Institute of Medical Sciences |
Department of Anaesthesiology, Pain Medicine and Critical Care, room no 5011, Ansari Nagar East, New Delhi- 110029
South
DELHI |
919968867172
purni89@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Hydronephrosis/ Pelviureteric junction obstruction, (1) ICD-10 Condition: N288||Other specified disorders of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal block |
The child is placed in lateral position. After cleaning and draping, a high frequency linear probe is placed transversely over the sacral cornu and the caudal canal is identified. The probe is then turned by 90 degrees. A 5cm needle is then inserted into the the caudal space using in-plane technique. After entering the caudal canal, 1.25ml/kg of 0.2% ropivacaine with 1:200000 adrenaline is injected after negative aspiration, under real time visualisation. |
| Intervention |
Paravertebral block |
The child is placed in lateral position. After cleaning and draping, a high-frequency linear probe is placed longitudinally over the T9/T10/T11 spinous processes. The probe is then moved laterally to identify the transverse processes. the paraertebral space is identified. Placing the probe in oblique position, the paravertebral is approached using an in-plane technique using a 19G Tuohy needle. 0.5ml/kg of 0.2% ropivacaine with 1:200000 adrenaline is injected after negative aspiration, under real time visualisation. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Age 2-10 years, ASA physical status I/II, Elective renal surgeries |
|
| ExclusionCriteria |
| Details |
Refusal by guardians or parents for their wards to participate in the study, Neurological deficit, History of sensitivity to drugs used in the study, Deformity of thoracolumbar spine or chest wall, Coagulopathy, Infection of the puncture site, Developmental delay, Cardiac disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of postoperative analgesia, when rescue analgesia is not required. The requirement is determined by FLACC score more than 3. |
zero, thirty minutes, first, second, third, sixth, twelfth and twenty fourth hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| stress response, parental satisfaction score |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/09/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of the study is to compare caudal and paravertebral block in terms of duration of analgesia. Paravertebral block appears to be superior. |