| CTRI Number |
CTRI/2019/12/022337 [Registered on: 12/12/2019] Trial Registered Prospectively |
| Last Modified On: |
13/12/2019 |
| 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
|
PAIN RELIEF AFTER SURGERY IN CHILDREN BY SPINAL AND CAUDAL ANAESTHESIA WITH BUPIVACAINE BY TWO TECHNIQUES |
|
Scientific Title of Study
|
POST OPERATIVE ANALGESIA USING TWO CONCENTRATIONS OF BUPIVACAINE(0.20% AND 0.15%) FOR CAUDAL EPIDURAL ANALGESIA (CEA) IN SEQUENTIAL CEA-SPINAL ANAESTHESIA IN CHILDREN POSTED FOR INFRA UMBILICAL SURGERIES |
| Trial Acronym |
SECEP-B |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Elavarasan R |
| Designation |
Junior Resident |
| Affiliation |
Vijayanagar Institute of Medical Sciences |
| Address |
Dept of Anaesthesiology,
VIMS,
Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9952749417 |
| Fax |
|
| Email |
elavarsanakash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bala Bhaskar S |
| Designation |
Professor |
| Affiliation |
Vijayanagar Institute of Medical Sciences |
| Address |
Dept of Anaesthesiology,
VIMS,Cantonment,
Ballari
Dept of Anaesthesiology,
VIMS,Cantonment,
Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9880012349 |
| Fax |
|
| Email |
sbalabhaskar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Elavarasan R |
| Designation |
Junior Resident |
| Affiliation |
Vijayanagar Institute of Medical Sciences |
| Address |
Dept of Anaesthesiology,
VIMS,
Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9952749417 |
| Fax |
|
| Email |
elavarsanakash@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of Anaesthesiology
VIMS
Bellari |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Elavarasan R |
Vijayanagar Institute of medical sciences |
Department of Anaesthesiology,
Major OT complex,
Cantonment, Ballari
Bellary
KARNATAKA |
9952749417
elavarsanakash@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) VIMS |
Approved |
| Institutional Ethical Committee (IEC) VIMS |
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 |
| Intervention |
BUPIVACAINE(0.15%) FOR CAUDAL EPIDURAL ANALGESIA (CEA) IN SEQUENTIAL CEA-SPINAL ANAESTHESIA |
Inj Bupivacaine 0.15% is used for caudal analgesia followed by Spinal Anaesthesia using Bupvacaine Heavy 0.5% |
| Comparator Agent |
Inj Bupivacaine 0.20% is used for caudal analgesia followed by Spinal Anaesthesia using Bupvacaine Heavy 0.5% |
BUPIVACAINE(0.20%) FOR CAUDAL EPIDURAL ANALGESIA (CEA) IN SEQUENTIAL CEA-SPINAL ANAESTHESIA |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1) Children of either sex posted for elective infra umbilical surgery
2) ASA physical status I & II
3) Age 2 to 8 years |
|
| ExclusionCriteria |
| Details |
1) Refusal by parents for the procedure
2) Children with spinal developmental anomalies
3) Significant coagulation, cardiovascular, respiratory, central nervous system or renal system disorders
4) Preexisting musculoskeletal disorders
5) Allergy to test drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative analgesia characteristics between to groups |
Assessment every 15 min for for 6 hrs, every 30 mins for 12 hrs, every 4 hrs for 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Use of supplements,PONV,Hemodynamic changes |
every 15th minute for 3hrs, every 30 mins for 12 hrs,every 4 hrs till 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Post operative analgesia in paediatric patients includes using caudal epidural analgesia. Spinal Anaesthesia is used frequently for providing surgical anaesthesia for infra umbilical surgeries. Combining both the techniques requires care in dosing requirements of local anaesthetic agents, to prevent toxicity. Keeping this in mind, this trial is planned using two different doses of bupivacaine (0.15% and 0.20%) for caudal epidural along with standard dose for spinal anaesthesia. First recruitment will start after approval by CTRI. |