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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03906019
Other study ID # GOKAEK 2019/85
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 9, 2019
Est. completion date April 30, 2019

Study information

Verified date July 2019
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 between the 1 September 2017 and 28 February 2019 and who received erector spinae plane blocks as a part of postoperative analgesia management will be scanned.


Description:

There are a few randomized prospective studies of ESPB for its clinical effectiveness and all of them are in adults, except one. Also pediatric case reports are limited when compared to adults. We have been applying ESPB to our patients almost since from its first definition. But ESPB applications for pediatric patients, in our clinic, have started after a learning curve. Patients who were operated by Department of Pediatric Surgery between the 1 September 2017 and 28 February 2019 and who received erector spinae plane blocks as a part of postoperative analgesia management will be scanned.

Demographical data of the patient, patient position for the block, indication/surgery type, level of ESPB, unilateral or bilateral application, total volume applied, additional analgesic use, type of the analgesic if used will be investigated.


Recruitment information / eligibility

Status Completed
Enrollment 141
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers
Gender All
Age group 1 Year 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:
ESP Block
Erector spinae plane block performed with 0,25% bupivacaine (0,5 mL/kg-max 20mL), under general anesthesia before the start of the surgery.
Diagnostic Test:
FLACC score
For up to 7 years old patients, Face, Legs, Activity, Cry and Consolability (FLACC) scores during postoperative 24h period.
NRS score
Patients older than 7 years, NRS scores during postoperative 24h period.

Locations

Country Name City State
Turkey Kocaeli University Hospital Izmit Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Rating Scale A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain. preoperative 24th hour
Primary Face, Legs, Activity, Cry and Consolability Score The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. postoperative 24th hour
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