| CTRI Number |
CTRI/2018/01/011327 [Registered on: 15/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Between Caudal Epidural And Ultrasound Guided Ilioinguinal-Iliohypogastric nerve block (both are techniques to reduce pain after inguinal hernia surgery) with Dexmedetomidine For pain relief after the inguinal hernia surgery in children; A Prospective, Randomised, study |
|
Scientific Title of Study
|
Comparison Between Caudal Epidural And Ultrasound Guided Ilioinguinal-Iliohypogastric block With Bupivacaine And Dexmedetomidine For Post-operative Analgesia Following Paediatric Inguinal Hernia Surgeries; A Prospective, Randomised, Double Blind Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varsha R |
| Designation |
post graduate |
| Affiliation |
SDM College of medical sciences and hospital |
| Address |
Department of Anaesthesia,SDM College of medical sciences and hospital, Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9481820424 |
| Fax |
|
| Email |
rudrahitluvarshask@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Desai guide |
| Designation |
Associate professor |
| Affiliation |
SDM College of medical sciences and hospital |
| Address |
Department of Anaesthesia,
SDM College of medical sciences and hospital, Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9480752566 |
| Fax |
|
| Email |
sameeranaes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha R |
| Designation |
post graduate |
| Affiliation |
SDM College of medical sciences and hospital |
| Address |
Department of Anaesthesia,SDM College of medical sciences and hospital, Sattur, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9481820424 |
| Fax |
|
| Email |
rudrahitluvarshask@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Medical Sciences and Hospital,
Sattur, Dharwad, Karnataka, pin number-580009 |
|
|
Primary Sponsor
|
| Name |
Dr Varsha R |
| Address |
Department of Anaesthesia,
SDM College of Medical Sciences, Sattur
Dharwad, Karnataka |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SDM College of Medical Sciences and Hospital |
Sattur, Dharwad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Varsha R |
SDM College of Medical Sciences and Hospital |
Department of Anaesthesiology, Sattur, Dahrwad, karnataka -580009
Dharwad
KARNATAKA |
9481820424
rudrahitluvarshask@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM insttutional ethical comite |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
children between 1 to 10 years undergoing unilateral inguinal hernial repair, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caudal Analgesia group |
After general anaesthesia, children received 0.75 ml.kg-1 of 0.25% bupivacaine with 1 mcg.kg-1 of dexmedetomidine in caudal epidural |
| Intervention |
ultrasound guided Ilioinguinal iliohypogastric nerve block |
After general anaesthesia, children recieved 0.25 ml.kg-1 of 0.25% bupivacaine with 1 mcg.kg-1 of dexmedetomidine in ultrasound guided IL/IH block |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA class I and II,
2. Age between age of 1 to 10 years,
3. Scheduled to undergo unilateral hernia and hydrocele repair |
|
| ExclusionCriteria |
| Details |
1. Children with active upper or lower respiratory tract infection
2. Bleeding disorders
3. Neuromuscular abnormalities
4. Deformities of the caudal space
5. Those allergic to NSAID’s or any of the other drugs used in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| paediatric pain score- FLACC |
postoperative period up to 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total analgesic consumption |
up 24 hours Postoperatively |
| Time for performance of Block |
Intraoperatively |
| Parents Satisfaction |
24 hours Postoperatively |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2015 |
| Date of Study Completion (India) |
15/11/2017 |
| 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
|
References:
1.A. M. El-Hennawy, A. M. Abd-Elwahab, A. M. Abd-Elmaksoud, H. S. El-Ozairy and S. R. Boulis. Addition of clonidine or dexmedetomidine to bupivacaine prolongs caudal analgesia in children. Br J Anaesth. 2009; 103: 268-74.
2.Willschke H, Marhofer P, Bösenberg A, Johnston S, Wanzel O, Cox SG, Sitzwohl C, Kapral S. Ultrasonography for ilioinguinal/iliohypogastric nerve blocks in children. Br J Anaesth. 2005 ;95:226-30.
3.Abdellatif AA. Ultrasound-guided ilioinguinal/iliohypogastric nerve blocks versus caudal block for postoperative analgesia in children undergoing unilateral groin surgery. Saudi J Anaesth. 2012;6:367-72.
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background
and Objectives:
Caudal Epidural and Ilioinguinal, Iliohypogastric nerve (IL/IH) Blocks are
commonly used regional anaesthesia techniques to provide post-operative analgesia
in paediatric inguinal surgeries. Dexmedetomidine as an adjuvant has proven to
prolong the duration of regional anaesthesia. There are no studies comparing
the analgesia provided by local anaesthetic with dexmedetomidine for caudal and
ultrasound guided IL/IH block for paediatric inguinal surgeries.
Materials
and Methods: Forty six patients undergoing inguinal hernia
repair were selected for this randomised double blind study. After general
anaesthesia, children received either 0.75 ml.kg-1 of 0.25%
bupivacaine with 1 mcg.kg-1 of dexmedetomidine in caudal epidural
group or 0.25 ml.kg-1 of 0.25% bupivacaine with 1 mcg.kg-1
of dexmedetomidine in ultrasound guided IL/IH block group. Postoperative pain
was assessed 24-hours postoperatively using FLACC score. For FLACC > 4,
rescue analgesia was provided using intravenous Fentanyl, within first 2-hours
and with oral Ibuprofen between 2-24 postoperative hours. The time for first
rescue analgesic was taken as the duration of analgesia.
Results: The duration of
analgesia of caudal and ultrasound guided IL/IH (USG-IL/IH) blocks were 730±430
minutes and 808±453 minutes respectively, which was statistically not
significant. Average time to perform caudal block was significantly higher
compared to IL/IH (547±93 vs. 317±179 seconds).There were no significant
complications in either group.
Conclusion:
Both
caudal epidural and USG-IL/IH block with dexmedetomidine are equally efficacious
in prolonging the analgesic duration with no significant side-effects. We found
that USG-IL/IH block was much faster and easier to perform as compared to
caudal epidural. |