Caudal Block Versus Local Wound Infiltration for Inguinal Procedures

Anesthesia, Caudal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04590027
• Other study ID #: 621/2013BO1
• Status: Completed
• Start date: February 1, 2014
• Est. completion date: January 30, 2020

Study information

• Verified date: August 2020
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 30, 2020
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 68 Months

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• no return of questionnaire

• parents do not understand language

Related Conditions & MeSH terms

• Anesthesia, Caudal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rescue Medication	total number of analgesic doses across all participants	24 hours
Secondary	Neurological Outcome	Time until first micturation an time to motor activity	24 hours