FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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-1Pain 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.


 
Close