CTRI Number |
CTRI/2019/02/017421 [Registered on: 04/02/2019] Trial Registered Prospectively |
Last Modified On: |
01/03/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A COMPARITIVE TRIAL OF ULTRASOUND GUIDED VERSUS CONVENTIONAL INJECTION FOR CAUDAL BLOCK IN CHILDREN UNDERGOING INFRA UMBILICAL SURGERIES |
Scientific Title of Study
|
A RANDOMIZED CONTROLLED TRIAL COMPARING ULTRASOUND GUIDED VERSUS CONVENTIONAL INJECTION FOR CAUDAL BLOCK IN CHILDREN UNDERGOING INFRA UMBILICAL SURGERIES |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Navya Sri Lalitha Kollipara |
Designation |
Post Graduate |
Affiliation |
SRI RAMACHANDRA UNIVERSITY |
Address |
Dr. Navya Sri Lalitha K.
Department of Anaesthesiology
Sri Ramachandra University, PORUR,CHENNAI
Chennai TAMIL NADU 600116 India |
Phone |
8106157890 |
Fax |
|
Email |
navya.kollipara@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
VRAJESH KUMAR KODALI |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
SRI RAMACHANDRA UNIVERSITY |
Address |
DEPARTMENT OF ANAESTHESIA,
SRI RAMACHANDRA UNIVERSITY,
PORUR, CHENNAI
Thiruvallur TAMIL NADU 600116 India |
Phone |
9444230150 |
Fax |
|
Email |
vrajesh.kodali@gmail.com |
|
Details of Contact Person Public Query
Modification(s)
|
Name |
VRAJESH KUMAR KODALI |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
Sri Ramachandra University, Porur, Chennai. |
Address |
DEPARTMENT OF ANAESTHESIA,
SRI RAMACHANDRA UNIVERSITY,
PORUR, CHENNAI
Thiruvallur TAMIL NADU 600116 India |
Phone |
9444230150 |
Fax |
|
Email |
vrajesh.kodali@gmail.com |
|
Source of Monetary or Material Support
|
Sri Ramachandra University |
|
Primary Sponsor
|
Name |
Sri Ramachandra University |
Address |
Department of Anaesthesiology Critical Care and Pain Medicine
Sri Ramachandra University,
Ramachandra Nagar, Porur
|
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 |
Navya Sri Lalitha |
Sri Ramachandra University |
Department of Anaesthesiology, Critical Care and Pain Medicine
Sri Ramachandra University,
Ramachandra Nagar, 600116
Chennai TAMIL NADU |
8106157890
navya.kollipara@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Comittee, Sri Ramachandra University |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
conventional caudal block |
routine conventional caudal block will be given by palpating the sacral hiatus |
Intervention |
Ultrasound Guided Caudal Block |
ultrasound will be used to adminster the caudal block |
|
Inclusion Criteria
|
Age From |
6.00 Month(s) |
Age To |
10.00 Year(s) |
Gender |
Both |
Details |
patients undergoing elective infra-umbilical surgeries with ASA physical status I and II |
|
ExclusionCriteria |
Details |
ASA physical status III and above
Emergency surgeries
Infection at the site of caudal injection
Sacral bone abnormalities
Bleeding disorders
Allergy to local anaesthetics
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
First puncture success rate |
Reaching sacral canal or sacral hiatus with a single needle orientation on 1st puncture without withdrawal from skin. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Block performing time |
Time from needle insertion to termination of local anaesthetic administration |
Successful block |
Defined as absence of limb movements and no increase in heart rate or mean arterial pressure above 15% from baseline on skin incision |
Complications(if any) |
Vascular puncture, subcutaneous tissue bulging,Dural puncture and local anaesthetic toxicity |
|
Target Sample Size
|
Total Sample Size="106" Sample Size from India="106"
Final Enrollment numbers achieved (Total)= "107"
Final Enrollment numbers achieved (India)="107" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
12/02/2019 |
Date of Study Completion (India) |
28/02/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
· Regional anaesthetic techniques are known to reduce the post-operative morbidity, provide early mobilisation and reduce opioid requirements. Caudal epidural block is a widely used regional anaesthetic technique especially in paediatric surgery to provide intraoperative and post-operative analgesia in surgeries below umbilical level(T10-S5 dermatomes). Conventional single shot caudal block technique involves the risk of dural or vascular puncture, intra osseous injection, soft tissue bulging and systemic toxicity. Many anatomic variations have been reported for sacral hiatus and sacral cornua. Therefore, success rate of classic caudal epidural technique has been reported to be about 75%. Ultrasonography is helpful for visualisation of the sacral hiatus, sacrococcygeal ligament, duramater, epidural space and distribution of local anaesthetic agent within the epidural space therefore significantly increases the block success rate. Indian data on caudal epidural block has been scarce and world over, the number of studies on ultrasound guided caudal epidural block is minimal. Hence we wish to conduct a randomised control study comparing ultrasound guided caudal block versus conventional caudal block in children undergoing elective infraumbilical surgeries. The primary outcome would be the first puncture success rate comparing both the arms. Other outcomes such as block performing time, success of the block and complications would also be assessed. The study would be conducted over a period of 6 months in the department of anaesthesia at a tertiary care centre hospital in southern India. |