CTRI Number |
CTRI/2020/08/026971 [Registered on: 04/08/2020] Trial Registered Prospectively |
Last Modified On: |
02/08/2020 |
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 effect of a drug with the same drug with one more additional drug administered through Caudal route for comparison of extent of pain relief in children undergoing lower abdominal surgery |
Scientific Title of Study
|
A randomised controlled study to compare the analgesic efficacy of Caudal Block between Bupivacaine alone and Bupivacaine with Morphine for post-operative analgesia in pediatric patients(01-05 years) undergoing lower abdominal surgeries |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Mayank Dhiman |
Designation |
Junior Resident |
Affiliation |
Command Hospital, Western Command , Chandimandir |
Address |
Department of Anaesthesia and Critical Care, Command Hospital, Western Command , Chandimandir
Panchkula HARYANA 134701 India |
Phone |
7018021052 |
Fax |
|
Email |
mustang8055@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
RDS Ahluwalia |
Designation |
Professor |
Affiliation |
Command Hospital, Western Command , Chandimandir |
Address |
Department of Anaesthesia and Critical Care, Command Hospital, Western Command , Chandimandir
Panchkula HARYANA 134107 India |
Phone |
8092893751 |
Fax |
|
Email |
ramandeepahluwalia@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
MAYANK DHIMAN |
Designation |
Junior Resident |
Affiliation |
Command Hospital, Western Command , Chandimandir |
Address |
Department of Anaesthesia and Critical Care, Command Hospital, Western Command , Chandimandir
Panchkula HARYANA 134701 India |
Phone |
7018021052 |
Fax |
|
Email |
mustang8055@gmail.com |
|
Source of Monetary or Material Support
|
Government institute
Command Hospital, Western Command, Chandimandir, Panchkula-134107. Haryana |
|
Primary Sponsor
|
Name |
Government institute |
Address |
Command Hospital, Western Command, Chandimandir |
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 |
Dr Mayank Dhiman |
Command Hospital , Western Command , Chandimandir |
Department of Anaesthesia and Critical Care, Command Hospital , Western Command , Chandimandir Panchkula HARYANA |
7018021052
mustang8055@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee Command Hospital (WC) Chandimandir |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: K40-K46||Hernia, (3) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (4) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Caudal Block |
Comparison of Bupivacaine vs Bupivacaine and Morphine |
Comparator Agent |
Caudal Block |
Comparison of Caudal analgesia with bupivacaine 0.25% (1 ml kg-1) and Caudal analgesia with bupivacaine 0.25% (1 ml kg-1 ) and morphine 40 mcg kg-1 |
|
Inclusion Criteria
|
Age From |
1.00 Year(s) |
Age To |
5.00 Year(s) |
Gender |
Both |
Details |
1.American Society of Anaesthesiology I and II physical status undergoing Lower Abdominal Surgeries |
|
ExclusionCriteria |
Details |
1. Allergic to study drugs
2. Cardiac, pulmonary,neurological and musculoskeletal diseases
3. Bleeding diathesis
4. Skin infection on back
5. Congenital anomalies of lower back
6. Patients requiring intra-operative analgesia in form of opioids
7. History of mental retardation and delayed milestones that may interfere with pain assessment
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the duration of caudal analgesia post operatively in paediatric patients aged 1-5 years undergoing lower abdominal surgery |
0,4,8,12,24 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study complications pertaining to caudal analgesia with bupivacaine and bupivacaine with morphine for post-operative analgesia in paediatric patients. |
0,4,8,12,24 hours |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
08/08/2020 |
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
|
the aim is to find out the best and safest modality of pain relief in pediatric patients |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Caudal injections of bupivacaine are
commonly used in children undergoing lower abdominal and urogenital surgery to
provide intraoperative analgesia. There is paucity of literature regarding use
of bupivacaine with morphine in caudal analgesia for post-operative analgesia.
This study has not been done earlier in our institute. Hence we plan to compare
efficacy and possible side effects of bupivacaine versus mixture of bupivacaine
and morphine when used in caudal analgesia for post-operative analgesia. A prospective,
randomized controlled study will be conducted on patient with ASA
I/II physical Status undergoing lower abdominal surgeries under
general anaesthesia after obtaining approval from the hospital ethics
committee. Prior written informed consent will be taken from parents of all the
patients in the language they understand. Total number of patients 100
will be enrolled and divided into two group: GROUP –I (n = 50) will be
receiving Caudal analgesia with bupivacaine 0.25% (1 ml kg-1)
GROUP-II (n = 50) will be receiving Caudal analgesia with bupivacaine 0.25% (1
ml kg-1 ) and morphine 40 mcg kg-1. Pain assessment will be done
using FLACC score which will be recorded at 0, 4, 8, 12 and 24 hrs after
surgery by the observer. Rescue analgesia will be given
for FLACC score ≥ 4 in the form of Inj. Paracetamol 15 mg kg-1 intravenous. The study will be a double blind randomly allocated design. Local or systemic
complications throughout the study will be recorded and managed accordingly. There is no
conflict of interest. |