Postoperative PainNCT05415046
Sacral Erector Spinae Plane Blocks 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 and who received sacral 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 month to 18 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Sacral ESPB
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 8 Jul 2022
- 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 month to 18 years
- All sexes
- Child, Adult
Study population: Patients who were operated by Department of Pediatric Surgery and performed sacral ESPB for postoperative analgesia.
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.
About this study
Official title: Retrospective Analyses of Sacral Erector Spinae Plane Blocks in Pediatric Patients: Is it Time to Discuss the Necessity of Caudal Block
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Sacral ESPB
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral ESPBProcedure or surgery
Erector spinae plane block performed with 0,25% bupivacaine (1 mL/kg-max 20mL), under general anesthesia before the start of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Sacral ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 24th hour.
Rescue analgesic-paracetamol
The need and amount of the IV paracetamol given
Measured: During the postoperative 24th hour.
Rescue analgesic-ibuprofen
The need and amount of the oral ibuprofen given
Measured: During the 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 posted10 Jun 2022
- Study start15 Jun 2022
- Primary completion7 Jul 2022
- Study completion8 Jul 2022
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can AKSU, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415046
- Sponsor's protocol ID
- GOKAEK-2021/6.04
- Status last verified
- Aug 2022
- First submitted
- 4 Jun 2022
- Last updated
- 17 Aug 2022
- 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 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analyses of Sacral Erector Spinae Plane Blocks in Pediatric Patients: Is it Time to Discuss the Necessity of Caudal Block
- ClinicalTrials.gov ID
- NCT05415046
- Acronym / sponsor ID
- GOKAEK-2021/6.04
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 10 Jun 2022 (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 and who received sacral erector spinae plane blocks as a part of postoperative analgesia management will be scanned.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacral ESPB | – | Procedure: Sacral ESPBSacral erector spinae plane block performed with 0,25% bupivacaine (1 mL/kg-max 20mL), under general anesthesia before the start of the surgery. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients who were operated by Department of Pediatric Surgery and performed sacral ESPB for postoperative analgesia.
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 |
|---|---|---|
| Sacral ESPBErector spinae plane block performed with 0,25% bupivacaine (1 mL/kg-max 20mL), under general anesthesia before the start of the surgery. | Procedure or surgery | Sacral ESPB |
Primary outcome
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.
Rescue analgesic-paracetamol
Time frame: During the postoperative 24th hour.
The need and amount of the IV paracetamol given
Rescue analgesic-ibuprofen
Time frame: During the postoperative 24th hour.
The need and amount of the oral ibuprofen given
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 17 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 17 Aug 2022. 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?
Face, Legs, Activity, Cry, Consolability (FLACC) Scale (time frame: Postoperative 24th hour.). The study lists 3 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 17 Aug 2022.