Caudal Block vs Local Wound Infiltration for Hernia Repair in Children

Study Overview
=================
Brief Summary
-----------------
To our knowledge there is still no study comparing the local wound infiltration by itself without ilio-inguinal and ilio-hypogastric nerve block and caudal anesthesia. The aim of this study was to evaluate anesthesia and recovery profile in pediatric patients after inguinal hernia repair with caudal block (CB) or local wound infiltration (LWI).

Detailed Description
-----------------
Total of 80 children aged 6 month to 7 years of ASA physical status I or II, undergoing unilateral hernia repair will be enroled in the study. One group will receive caudal block (CB) and the other group will receive local wound infiltration (LWI). Group CB will receive 1ml kg 0,25% bupivacaine and group LWI will receive 0,2 ml kg 0,25% bupivacaine. Data taken will than be analyzed and interpreted. Postoperative pain will be assess using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10)(8) and the Faces Legs Activity Cry Consolability tool (FLACC, 0-10)(9) at 30 min and 1, 2, and 3 h after operation. The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. Twenty-four hours after surgery, reports of delayed side-effects and demands for rescue acetaminophen from the child will be gathered. The investigator, who will be blind to the treatment group, will document these data with the medical records.

Official Title
-----------------
Evaluation of Anesthesia Profile in Pediatric Patients After Inguinal Hernia Repair With Caudal Block or Local Wound Infiltration

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Procedure: Bupivacain- Caudal
* Procedure: Bupivacaine- Local


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 month to 7 years ASA physical status I or II undergoing unilateral hernia repair Exclusion Criteria: history of developmental delay or mental retardation type I diabetes known or suspected coagulopathy known allergy to any local anesthetic known congenital anomaly of the spine signs of spinal anomaly or infection at the sacral or inguinal region

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacain -Caudal<br>Single shot Caudal Block will receive Group C with 1ml per kg Bupivacain 0,25%. | Procedure: Bupivacain- Caudal<br>* Bupivacain for caudal blocks, Group C received 1 ml kg of 0.25% (maximum volume 20 ml).<br>* Other names: Caudal block;|
| Active Comparator: Bupivacain- Local<br>Single shot Local Infiltration will receive Group L with 0,2ml per kg Bupivacain 0,25%. | Procedure: Bupivacaine- Local<br>* Bupivacain for Local Wound Infiltration Group L received 0,2 ml kg 0,25% (maximum volume 4 ml).<br>* Other names: Local Wound Infiltration;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Analgesic Requirement | The time to first supplemental oral acetaminophen demand (first acetaminophen time) was defined as the time from the end of surgery to the first registration of more than 4 on both CHEOPS and FLACC by the investigator. At t0. 30 min postoperative; t1 1h postoperative; t2 2h postoperative; t3 3h posoperative; t4 6h posoperative; t5 12h posoperative; t6 24h postoperative | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of oral acetaminophen | Total number of analgesic requirement | The number of analgesic received for the period of 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caudal block, local wound infiltration, hernia repair