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CTRI Number  CTRI/2018/03/012402 [Registered on: 07/03/2018] Trial Registered Retrospectively
Last Modified On: 05/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of three drugs used in anaesthesia for caudal block in children 
Scientific Title of Study   A comparative study of bupivacaine,ropivacaine and levobupivacaine in paediatric caudal block 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jagdeep Sharma 
Designation  Senior Resident 
Affiliation  Government Medical College And Hospital,Sector 32 Chandigarh 
Address  Department of Anaesthesia and Intensive Care,Fifth Floor, D-Block, Government Medical college and hospital, Sector- 32.

Chandigarh
CHANDIGARH
160030
India 
Phone  9988765759  
Fax    
Email  snehlatas222@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ruchi Gupta 
Designation  Professor 
Affiliation  SGRDIMSR 
Address  Department of Anaesthesia and Intesive care, Shri Guru Ram Das Institute of Medical Sciences and Research, Vallah.

Amritsar
PUNJAB
143501
India 
Phone    
Fax    
Email  drruchisgrd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jagdeep Sharma 
Designation  Senior Resident 
Affiliation  Government Medical College And Hospital,Sector 32 Chandigarh 
Address  Department of Anaesthesia and Critical Care, Fifth Floor, D-Block, Government Medical College and hospital ,sector - 32

Chandigarh
CHANDIGARH
160030
India 
Phone  9988765759  
Fax    
Email  snehlatas222@gmail.com  
 
Source of Monetary or Material Support  
Shri Guru Ram Das Institute of Medical sciences and Research, Amritsar 
 
Primary Sponsor  
Name  Dr Jagdeep Sharma 
Address  House No. 8419, New Maya Nagar, Haibowal Kalan , Ludhiana 
Type of Sponsor  Other [Self] 
 
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 
Jagdeep sharma  Shri Guru Ram Das Institute of Medical Sciences And Research  Main operation theatre/Second Floor/Department Of Anaesthesia and Critical Care.
Amritsar
PUNJAB 		 9988765759

snehlatas222@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sgrdimsr  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Healthy ASA-1 and ASA-2 Patients who consented to go under study,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caudal Block   Caudal epidural single shot block is given in paediatric patients under going infra umbilical surgeries 
Comparator Agent  levobupivacaine, bupivacaine and ropivacaine  these three regional anaesthetic drugs are given in three different groups. caudal effectiveness score and various other parameters are studied. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  90 patients of ASA grade I & II, undergoing infraumbilical surgery as circumscision, herniotomies, orchidopexies etc.  
 
ExclusionCriteria 
Details  Refusal by parents or guardian, pre existing neurological disease, hypersensitivity to local anaesthetics under study, bleeding diathesis or coagulation disorder, local sepsis at the site of puncture and technical problems such as persistent paresthesias or bloody/CSF tap. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Caudal Effectiveness Score among the three groups was assessed.  The Caudal Effectiveness score was assessed after administration of anaesthesia before beginning of the surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Mean pain scores, duration of post operative analgesia and associated compplications with the use of the drugs.  . The duration of postoperative analgesia in group I (levobupivacaine) was 126.15±15.15mins (2.10±0.25hrs), group II (ropivacaine) was 114.68±11.32mins (1.91±0.18hrs), group III (bupivacaine) was 145.31±15.15mins (2.42±0.43hrs. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/04/2013 
Date of Study Completion (India) 28/08/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="4"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   no publication as yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   There is limited data comparing all the three drugs. So, this study was performed to evaluate the caudal effectiveness of levobupivacaine, bupivacaine and ropivacaine in paediatric patients indergoing infra umbilical surgeries and associated complications with these drugs. This study also tried to find out difference in cardiac complications associated with these drugs.The diiference in mean caudal effectiveness score in all the three groups was statistically insignificant(p>0.05).21 patients in group I (Levobupivacaine), 19 patients in group II( Ropivacaine) and 22 patients in group III(Bupivacaine) had a caudal effectiveness score of 3. Mean postoperative pain scores as assessed with modified hanallah pain score were lower in bupivacaine group as compared to levobupivacaine and ropivacaine group during 1st hour post operatively. The duration of post operative analgesia in group I(levobupivacaine) was 126.15 mins, group II ropivacaine was 114.68 mins, and bupivacaine was 145.31 mins. The difference in duration of post operative analgesia was statistically highly significant.(p<0.001).Levobupivacaine and ropivacaine provided similar duration of post operative analgesia. Bupivacaine provided longer duration of analgesia than levobupivacaine and ropivacaine.
 
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