| CTRI Number |
CTRI/2025/05/086595 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial comparing most effective pain relief after surgery among the two blocks given for children undergoing open hernia surgery.
|
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Scientific Title of Study
|
Post operative analgesic efficacy of ultrasound guided caudal epidural block compared to retrolaminar block for elective unilateral open inguinal hernia repair in children: a randomized double blind controlled trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vinod hosalli |
| Designation |
Professor |
| Affiliation |
Sapthagiri institute of medical sciences,Bamngalore |
| Address |
Department of Anaesthesiology
sapthagiri superspeciality hospital
ground floor
Number 15
Chikkasandra
Hesaraghatta main road
Number 15 Chikkasandra
Hesaraghatta main road
Bangalore
Karnataka 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
08022188702 |
| Fax |
|
| Email |
simsanaesthesiology@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vinod hosalli |
| Designation |
Professor |
| Affiliation |
Sapthagiri institute of medical sciences,Bamngalore |
| Address |
Department of Anaesthesiology
ground floor
Sapthagiri superspeciality Hospital
Number 15 Chikkasandra
Hesaraghatta main road
Department of Anaesthesiology
ground floor
Sapthagiri superspeciality Hospital
Number 15 Chikkasandra
Hesaraghatta main road
Bangalore
KARNATAKA
560090
India |
| Phone |
08022188702 |
| Fax |
|
| Email |
simsanaesthesiology@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
vinod hosalli |
| Designation |
Professor |
| Affiliation |
Sapthagiri institute of medical sciences,Bamngalore |
| Address |
Department of Anaesthesiology
ground floor
Sapthagiri superspeciality Hospital
Number 15 Chikkasandra
Hesaraghatta main road
Department of Anaesthesiology
ground floor
Sapthagiri superspeciality Hospital
Number 15 Chikkasandra
Hesaraghatta main road
Bangalore
KARNATAKA
560090
India |
| Phone |
08022188702 |
| Fax |
|
| Email |
simsanaesthesiology@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sapthagiri institute of Medical sciences |
| Address |
Department of Anaesthesiology
Sapthagiri institute of medical sciences
No 15 Chikkasandra
Hesaraghatta main road, Bangalore 560090 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinod Hosalli |
Sapthagiri superspeciality hospital |
Department of Anaesthesiology
ground floor
Number 15 Chikkasandra
Hesaraghatta main road
Bangalore
KARNATAKA |
8310268837
simsanaesthesiology@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri institute of medical sciences and research center institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ultrasound guided caudal epidural block |
A single shot caudal block will be performed under aseptic precautions using 22g needle in left lateral decubitus position and 1.0ml per kg of 0.25 percent Bupivacine will be injected carefully after negative aspiration. |
| Comparator Agent |
Ultrasound guided retrolaminar block |
A single shot retrolaminar block will be performed at T12 level, under aseptic precaution, in lateral position with ultrasound probe in sagittal orientation, using 22 G needle and Bupivacaine 0.25 percent of 0.5 ml per kg will be injected |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1.All the patients scheduled for for elective unilateral open inguinal hernia repair under general anaesthesia.
2.ASA physical status I and II
3.Age 2-6 years
|
|
| ExclusionCriteria |
| Details |
1.Patients with known allergies to local anaesthetics.
2.Unwillingness to participate in the study
3.Infection at injection site
4.Coagulation disorders
5.Liver and kidney disease.
• Children with active respiratory tract infection.
• Patients having a history of mental retardation/developmental delay
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the post-operative analgesic efficacy between Caudal epidural block and Retrolaminar block in children undergoing elective unilateral open inguinal hernia repair |
Post-operative pain will be assessed with FLACC scale at 1,2,4,6,12 and 24 hours post surgery.Rescue analgesia will be given if FLACC score is more than three. For the first 2 hour Fentanyl 1mcg per kg ( every 15 minutes duration) and between 2 to 24 hour, oral Ibuprofen 10 mg per kg (maximum dose 10mg per kg every 8 hour) will be used. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
.Adverse events: nausea, vomiting, hypotension, urinary retention
2.Parental & surgeon satisfaction scale (5-point Likert scale).
|
Parental & surgeon satisfaction scale (5-point Likert scale), post-operative adverse events such as nausea, vomiting, hypotension, urinary retention will be recorded for 24 hour period post surgery |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/05/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study is a randomized double controlled trial, comparing the analgesic efficacy of ultrasound guided caudal epidural block with retrolaminar block using bupivcaine.The primary aim of this study, is to compare the postoperative analgesic efficacy of both the blocks,by using duration of post-operative analgesia and time to first
rescue analgesic requirement. Secondary outcome includes, number of patients
requiring rescue analgesia, total analgesic consumption in the first 24h post
operatively, adverse events and parental and surgeon satisfaction score.Fifty children undergoing elective unilateral open inguinal hernia repair will
be enrolled in the study
Post-operative pain will be assessed with FLACC
score and rescue analgesia will be given if FLACC score is more than three.Time to first
rescue analgesic requirement, number of rescue analgesics in 24 hour period, parental
and surgeon satisfaction,post-operative adverse events such as nausea, vomiting, hypotension,
urinary retention will be recorded.
|