| CTRI Number |
CTRI/2022/07/043668 [Registered on: 04/07/2022] Trial Registered Prospectively |
| Last Modified On: |
28/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of ultrasound for location of epidural space for pain after surgery in children. |
|
Scientific Title of Study
|
COMPARISON OF ANALGESIC EFFICACY OF CAUDAL BLOCK WITH OR WITHOUT USING ULTRASOUND TECHNIQUE IN CHILDREN UNDERGOING INFRAUMBILICAL 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 Ruchi Gupta |
| Designation |
Prof and Head |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia,
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9814320805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaganjot Kaur |
| Designation |
Assistant Prof |
| Affiliation |
SGRDIMSAR |
| Address |
Department of Anaesthesia,
SGRDIMSAR, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
8198014504 |
| Fax |
|
| Email |
drgaganjot@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Randeep Kaur |
| Designation |
Junior Resident |
| Affiliation |
SGRDIMSAR |
| Address |
Department of Anaesthesia,
SGRDIMSAR, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
|
| Fax |
|
| Email |
randeepsandhu78@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGRDIMSAR
Mehta Road, Vallah |
|
|
Primary Sponsor
|
| Name |
SGRDIMSAR |
| Address |
Mehta Road, Vallah |
| 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 Ruchi Gupta |
Operation Theatre |
Department of Anaesthesia,
Sri Guru Ram Das Institute of Medical Sciences and Research
Mehta Road, Vallah
Amritsar
Amritsar
PUNJAB |
9814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD ethical committe |
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 |
| Comparator Agent |
0.25% bupivacaine (1ml/kg) with or without dexamethasone(0.1 mg/kg) |
Analgesic efficacy of drugs(0.25% bupivacaine (1ml/kg) with or without dexamethasone(0.1 mg/kg))via caudal block |
| Intervention |
Caudal Block |
Analgesic efficacy of caudal block using ultrasound and landmark technique in children undergoing infraumbilical surgeries |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I, II
Children undergoing infra umbilical surgeries
|
|
| ExclusionCriteria |
| Details |
1.Children with pre-existing neurological disease
2.Children with known hypersensitivity to local anaesthetic agents.
3.Children suffering from bleeding diathesis or coagulation disorders.
4.Local sepsis at the site of proposed puncture.
5.Sacral deformity or tuberculosis of spine.
6.Children being treated with anticoagulants, CNS active drugs.
7.Technical problems (persistent parasthesias, persistent bloody tap).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the analgesic efficacy of caudal block with or without using ultrasound technique in children undergoing infraumbilical surgeries
1. To evaluate analgesic efficacy of caudal block in terms of –
a. Caudal effective score
b. Hemodynamic stability
c. Recovery profile
2. To study the complications of procedure and side effects of drug.
|
from the start of anaesthesia till 24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the analgesic efficacy of caudal block with Bupivacaine alone or with dexamethasone using ultrasound technique in children undergoing infraumbilical surgeries
|
from the start of anaesthesia till 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/07/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
no |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Caudal block is a popular and reliable technique in pediatric surgeries. Ultrasound guided caudal block is known to improve the success rate and reduce the complications noted with the landmark technique. We aimed to conduct a study to evaluate analgesic efficacy of caudal block in pediatric patients with or without ultrasound technique as primary outcome in infra umbilical surgeries. Patients will be randomly allocated according to 105 computer generated coded slips and sealed in an envelope and divided into three groups of 35 patients each. |