Caudal Block Versus Local Wound Infiltration for Inguinal Procedures

Study Overview
=================
Brief Summary
-----------------
Single-centre observational study to analyse whether there is a difference in post-operative pain scores and set up time when comparing caudal block with local wound infiltration

Detailed Description
-----------------
Inguinal procedures in children are surgical frequently performed in an outpatient setting. This study analyzed regional analgesia for inguinal procedures in toddlers comparing caudal block with local wound infiltration and assessed post-operative pain scores as well as process times.A number of documents were compiled to inform and record data: a standard anaesthesia protocol, a documentation sheet for intraoperative recording, an information leaflet for the parents and a documentation sheet for the post-operative course of 24 hours . Caudal anaesthesia was performed after induction of anaesthesia. In patients getting wound infiltration ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis. Parents were informed about the study and invited to participate upon arriving on the outpatient ward if the patient fulfilled the following inclusion criteria: scheduled for elective inguinal procedure, age three to 72 months, no contraindication for either local or caudal analgesia, no comorbidities. If parents agreed to participate, written informed consent was obtained. Pain score and administration of analgesics, vomiting, interval until micturition and interval until mobilization as well as sleep quality during the first post-operative night were documented by the parents in the provided booklet.

Official Title
-----------------
Caudal Block Versus Local Wound Infiltration for Inguinal Procedures in Young Children. A Prospective Observational Trial

Conditions
-----------------
Anesthesia, Caudal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: no return of questionnaire parents do not understand language

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 68 Months

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Analgesia Quality Between the Two Groups | Visual Analog Score (VAS) Minimum 0 (no pain) and Maximum 10 (worst pain) A two point difference of mean pain scores was defined as clinically meaningful to establish a superiority for one of the procedures of pain management | Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h, | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Set up Time | How much times goes by for induction of anesthesia in both groups | Time in minutes measured between start of induction of anesthesia to start of surgical incision | 
| Rescue Medication | total number of analgesic doses across all participants | 24 hours | 
| Neurological Outcome | Time until first micturation an time to motor activity | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caudal block, wound infiltration, postoperative pain, outpatient surgery