| CTRI Number |
CTRI/2018/08/015288 [Registered on: 13/08/2018] Trial Registered Prospectively |
| Last Modified On: |
08/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare two methods of pain relief after the surgery in children |
|
Scientific Title of Study
|
A comparative study of analgesic efficacy of caudal Ropivacaine with clonidine or dexamethasone as adjuvants in paediatric infraumbilical surgeries – An open labelled Randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushpalatha D S |
| Designation |
consultant |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Department of anaesthesia,
operation theatre,1st floor
Bangalore Baptist Hospital Bellary Road Hebbal Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
|
| Fax |
|
| Email |
pushpa.bettari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
kavyashree |
| Designation |
Anaesthesia resident |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Department of anaesthesia
operation theatre, 1st floor Bangalore Baptist Hospital Bellary Road Hebbal Bangalore
d/o Ramakrishnareddy K B
205,2nd floor,
1st A main,M venkategowda layout, Hebbal kempapura
Bangalore
KARNATAKA
560024
India |
| Phone |
9141920884 |
| Fax |
|
| Email |
kavyashree.daanu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
kavyashree |
| Designation |
Anaesthesia resident |
| Affiliation |
Bangalore Baptist Hospital |
| Address |
Department of anaesthesia
operation theatre, 1st floorBangalore Baptist Hospital Bellary Road Hebbal Bangalore
d/o Ramakrishnareddy K B 205,2nd floor,
1st A main,M venkategowda layout, Hebbal kempapura
Bangalore
KARNATAKA
560024
India |
| Phone |
9141920884 |
| Fax |
|
| Email |
kavyashree.daanu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesia
1st floor, Bangalore Baptist Hospital Hebbal Karnataka |
|
|
Primary Sponsor
|
| Name |
Bangalore Baptist Hospital |
| Address |
Bangalore Baptist Hospital Bellary Road Hebbal Bangalore |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 kavyashree |
Bangalore Baptist Hospital |
Department of anaesthesia Operation theatre ,1st floor Bangalore Baptist Hospital Bellary Road Hebbal Bangalore
Bangalore
KARNATAKA |
9620654034
kavyashree.daanu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Baptist Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pediatric age group between 1 to 10 years posted for infraumbilical surgeries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
analgesic efficacy of caudal ropivacaine with clonidine |
Caudal Ropivacaine 0.2% 1ml/kg and Clonidine 1mcg/kg |
| Intervention |
Analgesic efficacy of caudal Ropivacaine with dexamethasone |
Caudal Ropivacaine 0.2% 1ml/kg and Dexamethasone 0.1mg/kg |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
• Age between 1 to 10 years
• weight of child less than 30kg
• American Society of Anesthesiologists (ASA) grade I and II patients
• Children posted for infraumbilical surgeries less than 2 hour duration (herniotomy, urethroplasty,circumcision, orchidopexy, lower limb orthopaedic surgeries etc)
|
|
| ExclusionCriteria |
| Details |
1. Children posted for emergency surgery
2. Infection at the site of injection
3. Coagulopathy or on anticoagulation therapy
4. Congenital anomaly of lower spine and meninges
5. Active disease of the CNS
6. History of allergy to local anaesthetics, Clonidine and Dexamethasone
7. Surgeries in prone position
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of ropivacaine with clonidine or dexamethasone as adjuvants for caudal epidural block in paediatric infraumbilical surgeries. |
To evaluate duration of analgesia (defined as time from caudal injection until the first requirement of rescue analgesia, pain assessed by FLACC).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess haemodynamic stability between the two groups.
2. To assess incidence of any side effects like nausea and vomiting, sedation, bradycardia, hypotension, wound infection
|
up to 12 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
16/08/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Caudal block is common regional technique used to provide postoperative pain in paediatric patients, many adjuvants are used with local anaesthetics to increase duration of analgesia to minimise the side effect of toxicity of local anaesthetic. In our study we compare analgesic efficacy of caudal Dexamethasone or Clonidine as adjuvants with ropivacaine. |