Postoperative PainNCT03906019
Indications of Erector Spinae Plane Block in Pediatric Patients
An observational study of Postoperative Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ESP Block, FLACC score and NRS score
- Type of treatment
- Surgery or procedure
- How many people
- 141 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2019to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- Patients who were operated by Department of Pediatric Surgery
Who cannot join
- Incomplete patient forms
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Hospital
İzmit, Kocaeli, 41340
About this study
Official title: Defining the Indications and Levels of Erector Spinae Plane Block in Pediatric Patients: A Retrospective Study About Our Current Experience
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.
Read the detailed 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.
- Conditions
- Postoperative Pain
- Being tested
- ESP Block, FLACC score, NRS score
- Keywords
- erector spinae plane block, postoperative pain, pediatric patients
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP BlockProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start9 Apr 2019
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can AKSU, Kocaeli University
- Investigators
- Can Aksu, Assistant Professor, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906019
- Sponsor's protocol ID
- GOKAEK 2019/85
- Status last verified
- Jul 2019
- First submitted
- 4 Apr 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Indications and Levels of Erector Spinae Plane Block in Pediatric Patients: A Retrospective Study About Our Current Experience
- ClinicalTrials.gov ID
- NCT03906019
- Acronym / sponsor ID
- GOKAEK 2019/85
- Conditions
- Postoperative Pain
- Keywords
- erector spinae plane block, postoperative pain, pediatric patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Patients who were operated by Department of Pediatric Surgery
Key exclusion criteria (1 listed)
- Incomplete patient forms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESP BlockErector spinae plane block performed with 0,25% bupivacaine (0,5 mL/kg-max 20mL), under general anesthesia before the start of the surgery. | Procedure or surgery | – |
| FLACC scoreFor up to 7 years old patients, Face, Legs, Activity, Cry and Consolability (FLACC) scores during postoperative 24h period. | Diagnostic test | – |
| NRS scorePatients older than 7 years, NRS scores during postoperative 24h period. | Diagnostic test | – |
Primary outcome
Numeric Rating Scale
Time frame: preoperative 24th hour
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.
Face, Legs, Activity, Cry and Consolability Score
Time frame: postoperative 24th hour
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Can Aksu, Assistant Professor principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: preoperative 24th hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.