- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05415046
Sacral Erector Spinae Plane Blocks in Pediatric Patients
Retrospective Analyses of Sacral Erector Spinae Plane Blocks in Pediatric Patients: Is it Time to Discuss the Necessity of Caudal Block
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Kocaeli, Turkey
- Kocaeli University Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who were operated by Department of Pediatric Surgery
Exclusion Criteria:
- Incomplete patient forms
Study Plan
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.
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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.
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Rescue analgesic-paracetamol
Time Frame: During the postoperative 24th hour.
|
The need and amount of the IV paracetamol given
|
During the postoperative 24th hour.
|
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Rescue analgesic-ibuprofen
Time Frame: During the postoperative 24th hour.
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The need and amount of the oral ibuprofen given
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During the postoperative 24th hour.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOKAEK-2021/6.04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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