Caudal Block Versus Local Wound Infiltration for Inguinal Procedures

NCT04590027 | Completed Results

• 1 other identifier: 621/2013BO1
• Study Type: observational
• Target: 86
• Locations: 0 countries
• Sites: N/A

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

Conditions

Anesthesia, Caudal

Keywords

caudal block; wound infiltration; postoperative pain; outpatient surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Set up Time

  Time in minutes measured between start of induction of anesthesia to start of surgical incision

• Rescue Medication

  24 hours

• Neurological Outcome

  24 hours

Eligibility Criteria

• Age: 3 Months - 68 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• no return of questionnaire
• parents do not understand language

Sponsors & Collaborators

• University Hospital Tuebingen: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Since postoperative pain and emergence delirium might overlap within the first half hour after the procedure, a paediatric anaesthesia emergence delirium scale might have been useful.

Results Point of Contact

• Title: Dr. Barbara Schlisio
• Organization: University of Tuebingen, Department of Anaesthesiology and Intensive Care Medicine

barbara.schlisio@med.uni-tuebingen.de

+4970712985535

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 19, 2020
• Study Start: February 1, 2014
• Primary Completion: June 30, 2015
• Study Completion: January 30, 2020
• Last Updated: July 14, 2021
• Results First Posted: July 14, 2021

Record last verified: 2020-08