Sacral Erector Spinae Plane Blocks in Pediatric Patients

August 16, 2022 updated by: Can AKSU, Kocaeli University

Retrospective Analyses of Sacral Erector Spinae Plane Blocks in Pediatric Patients: Is it Time to Discuss the Necessity of Caudal Block

Patients who were operated by Department of Pediatric Surgery and who received sacral erector spinae plane blocks as a part of postoperative analgesia management will be scanned.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Erector spinae plane block (ESPB) is a safe and effective regional anesthesia technique in pediatric patients and can be performed at any level of the thoracic and lumbar vertebrae. In addition, ESPB can be performed at the sacral region in the midline. In pediatric patients, sacral ESPB provides effective analgesia and this method can replace caudal blocks.

This study aims to investigate the efficacy of sacral ESPB retrospectively. Demographical data of the patient, indication/surgery type, total volume applied, additional analgesic use, type of the analgesic if used will be investigated.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kocaeli, Turkey
        • Kocaeli University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who were operated by Department of Pediatric Surgery and performed sacral ESPB for postoperative analgesia.

Description

Inclusion Criteria:

  • Patients who were operated by Department of Pediatric Surgery

Exclusion Criteria:

  • Incomplete patient forms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sacral ESPB
Sacral erector spinae plane block performed with 0,25% bupivacaine (1 mL/kg-max 20mL), under general anesthesia before the start of the surgery.
Erector spinae plane block performed with 0,25% bupivacaine (1 mL/kg-max 20mL), under general anesthesia before the start of the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Time Frame: Postoperative 24th hour.
The scale is scored in a range of 0-10 with 0 representing no pain (meaning a better outcome). The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Postoperative 24th hour.
Rescue analgesic-paracetamol
Time Frame: During the postoperative 24th hour.
The need and amount of the IV paracetamol given
During the postoperative 24th hour.
Rescue analgesic-ibuprofen
Time Frame: During the postoperative 24th hour.
The need and amount of the oral ibuprofen given
During the postoperative 24th hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Actual)

July 7, 2022

Study Completion (Actual)

July 8, 2022

Study Registration Dates

First Submitted

June 4, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • GOKAEK-2021/6.04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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