Clinical Trials Directory

Trials / Completed

CompletedNCT04590027

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

Status
Completed
Phase
Study type
Observational
Enrollment
86 (actual)
Sponsor
University Hospital Tuebingen · Academic / Other
Sex
All
Age
3 Months – 68 Months
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2014-02-01
Primary completion
2015-06-30
Completion
2020-01-30
First posted
2020-10-19
Last updated
2021-07-14
Results posted
2021-07-14

Source: ClinicalTrials.gov record NCT04590027. Inclusion in this directory is not an endorsement.