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CTRI Number  CTRI/2018/04/013101 [Registered on: 09/04/2018] Trial Registered Retrospectively
Last Modified On: 28/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare two drugs, levobupivacaine, tramadol and their combination for postoperative pain relief in children 
Scientific Title of Study   A clinical study to compare caudal Levobupivacaine, Tramadol alone and in combination for post operative analgesia in paediatric inguinal hernia surgeries 
Trial Acronym  CALT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neelam Dogra 
Designation  Professor 
Affiliation  Sawai Man Singh medical college 
Address  Department of Anaesthesia,Operation theatre complex,Sir Padmapat Mother and Child Institute, J.L.N. Marg, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9928709289  
Fax    
Email  neelam_dogra24@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Neelam Dogra 
Designation  Professor 
Affiliation  Sawai Man Singh medical college 
Address  Department of Anaesthesia, Operation Theatre complex, Sir Padmapat Mother and Child Institute, J.L.N. marg, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9928709289  
Fax    
Email  neelam_dogra24@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Neelam Dogra 
Designation  Professor 
Affiliation  Sawai Man Singh medical college 
Address  Department of Anaesthesia, Operation Theatre complex, Sir Padmapat Mother and Child Institute, J.L.N. marg, Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9928709289  
Fax    
Email  neelam_dogra24@yahoo.com  
 
Source of Monetary or Material Support  
Sawai Man Singh Medical College, J.L.N. Marg, Jaipur, Rajasthan. Pin Code-302004 
 
Primary Sponsor  
Name  Sawai Man Singh Medical College 
Address  J.L.N. Marg, Jaipur 
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 
Rajat Dadheech  Sawai Man Singh Medical College  J.L.N. marg, Jaipur
Jaipur
RAJASTHAN 
7597607231

rajatdadheech.rd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee, SMS Medical college and Attached Hospitals Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Children with inguinal hernia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caudal block with levobupivacaine  Caudal block given before surgery in children with 1 ml/kg of 0.125% levobupivacaine 
Comparator Agent  Caudal block with levobupivacaine plus tramadol  Caudal block given before surgery in children with 1 ml/kg solution of normal saline containing 0.125% levobupivacaine and 1.5 mg/kg tramadol 
Intervention  Caudal block with tramadol  Caudal block given before surgery in children with 1 ml/kg solution of normal saline containing 1.5 mg/kg tramadol 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Children beloning to American Society of Anaesthesioloists grade I & II planned for inguinal herniotomy surgeries. 
 
ExclusionCriteria 
Details  Patients undergoing emergency procedures, parental refusal to participate and children having a bleeding disorder or vertebral defects. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia  Duration of analgesia 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of motor blockade, total number of rescue analgesic doses required and recording of any adverse effects in the form of respiratory depression (rate less than 10 per minute or requiring supplemental oxygen), bradycardia, nausea and vomiting  Time to reach modified bromage scale to zero. 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   08/03/2013 
Date of Study Completion (India) 07/11/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

 

Background and Aims:

Caudal block is a safe and simple method of pain relief in young children with the drawback of a short duration of analgesia which can be overcome by adding various adjuvants to the injected local anaesthetic. We compared the effects of caudal levobupivacaine, tramadol and a combination of both in paediatric patients undergoing inguinal herniotomy.

Method:

After permission from the hospital ethics committee, in this randomised double blinded interventional study 78 children aged 1 to 7 years, planned for inguinal herniotomy were randomly allocated to 3 groups. Group L was administered levobupivacaine 0.125% 1ml/kg, Group T received tramadol 1.5 mg/kg in 0.9% NS and Group LT 1ml/kg of 0.125% levobupivacaine with 1.5mg/kg tramadol caudally. Observations were made for postoperative pain, rescue analgesic doses and any adverse effects for 12 hours postoperatively. The quantitative data collected was analysed by ANOVA test.

Results:

All the groups were comparable with regards to age, sex and duration of surgery. No motor block was observed in any of the patients. The mean duration of analgesia in Group L was 321.46 + 84.76 minutes and in Group T was 565.19 + 107.08 minutes. The requirement for rescue analgesia in tramadol group was significantly less as compared to levobupivacaine group. In contrast, none of the patients in Group LT required additional analgesia during the 12-hour study period. Sedation scores and adverse effects were comparable among all groups.

 

Conclusion:

Addition of tramadol to caudal levobupivacaine significantly increased the duration and effectiveness of postoperative analgesia.

 
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