NCT03906019

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

April 9, 2019

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

21 days

First QC Date

April 4, 2019

Last Update Submit

July 31, 2019

Conditions

Postoperative Pain

Keywords

erector spinae plane blockpostoperative painpediatric patients

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

ESP BlockPROCEDURE

Erector spinae plane block performed with 0,25% bupivacaine (0,5 mL/kg-max 20mL), under general anesthesia before the start of the surgery.

FLACC scoreDIAGNOSTIC_TEST

For up to 7 years old patients, Face, Legs, Activity, Cry and Consolability (FLACC) scores during postoperative 24h period.

NRS scoreDIAGNOSTIC_TEST

Patients older than 7 years, NRS scores during postoperative 24h period.

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • Patients who were operated by Department of Pediatric Surgery

You may not qualify if:

  • Incomplete patient forms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Hospital

İzmit, Kocaeli, 41340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Can Aksu, Assistant Professor

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 8, 2019

Study Start

April 9, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

August 1, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)