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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05415046
Other study ID # GOKAEK-2021/6.04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2022
Est. completion date July 8, 2022

Study information

Verified date August 2022
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 8, 2022
Est. primary completion date July 7, 2022
Accepts healthy volunteers
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria: - Patients who were operated by Department of Pediatric Surgery Exclusion Criteria: - Incomplete patient forms

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Kocaeli University Hospital Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Face, Legs, Activity, Cry, Consolability (FLACC) Scale 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.
Primary Rescue analgesic-paracetamol The need and amount of the IV paracetamol given During the postoperative 24th hour.
Primary Rescue analgesic-ibuprofen The need and amount of the oral ibuprofen given During the postoperative 24th hour.
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