Caudal Block Versus Local Wound Infiltration for Inguinal Procedures

Completed

• Conditions: Anesthesia, Caudal

• Registration Number: NCT04590027
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study Start: 2014-02-01
• Primary Completion: 2015-06-30
• Study Completion: 2020-01-30
• Status Verified: 2020-08
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Results First Submitted: 2021-02-23
• Results First Submitted QC: 2021-06-22
• Last Update Submitted: 2021-06-22
• Results First Posted: 2021-07-14
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Exclusion Criteria

• no return of questionnaire
• parents do not understand language

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of Analgesia Quality Between the Two Groups	Arrival on postoperative care unit (PCU), arrival ward, 1h, 2 h 3h, 4h, 5h, 6h, 12h. 24h,	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

Secondary Outcome Measures

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