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
|
|
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
|
|
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. |