Caudal Block Versus Local Wound Infiltration for Inguinal Procedures

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia, Caudal

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.

• Study Type: Observational
• Enrollment (Actual): 86

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatient setting

paediatric inguinal procedures classifeind ASA 1 or 2 perfomed from the department of paediatric surgery

Description

Inclusion Criteria:

-

Exclusion Criteria:

• no return of questionnaire
• parents do not understand language

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): June 30, 2015
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: postoperative pain; outpatient surgery; caudal block; wound infiltration
• Other Study ID Numbers: 621/2013BO1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No