Scoliosis IdiopathicPhase 4ESPBNCT05938959
Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery
A Phase 4 study testing ESPB in people with Scoliosis Idiopathic, run by Poznan University of Medical Sciences at 2 sites in Poland.
Trial summary
The study aims to assess the effect of the interfacial plane blocks on the pain level, the course of postoperative rehabilitation, and its anti-inflammatory analgesic effect. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- ESPB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesPoland
- Study dates
- 1 May 2023to 1 Sep 2024
- Phase
- Phase 4
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 10-18 years old
- pediatric patients who will undergo the surgical correction of idiopathic scoliosis
Who cannot join
- a history of chronic pain (use of gabapentin/pregabalin for > 3 months or opioid use > 1 repeated opioid prescription in the last three months)
- morbid obesity (BMI > 99th percentile)
- previous surgery
- back abnormalities
- infection at block application area
- coagulopathy
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
Poznan, Wielkopolska, 61-545
Tomasz Kotwicki, Profesor, +48618310157, kckod@ump.edu.pl
- Recruiting
Poznan University of Medical Sciences
Poznan
Grzegorz Kowalski, PhD, gkowalski@ump.edu.pl
About this study
Official title: Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.
The study aims to assess the effect of the interfacial plane blocks on the pain level, the course of postoperative rehabilitation, and its anti-inflammatory analgesic effect.
Read the detailed description
This study evaluates the analgesic efficacy in adolescents of bilevel, bilateral erector spinae plane (ESP) blocks after posterior spinal fusion surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We aim to investigate how ESP blocks, performed under ultrasound guidance at the two vertebral levels, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until the patient is discharged from the hospital. These primary outcome measures will be compared between a treatment group of participants receiving ESP blocks and a control group receiving a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements.
- Conditions
- Scoliosis Idiopathic
- Being tested
- Sham block, ESPB
- Keywords
- pain management, peripheral nerve block, erector spinae plane block, euromonitoring
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham blockDrug
Also called 0,9% normal saline
Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0,9% normal saline
ESPBDrug
Also called 0,2% ropivacaine
Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0.2% Ropivacaine (max 2.5mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Sham group | Active comparator | Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0,9% Normal Saline Receives: Drug: Sham block |
| ESPB group | Active comparator | Bilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0.2% Ropivacaine (max 2.5mg/kg) Receives: Drug: ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Measured: 30 minutes after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Measured: 60 minutes after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Measured: 90 minutes after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Measured: 120 minutes after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Measured: 6 hours after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Measured: 12 hours hours after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Measured: 24 hours after surgery
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Measured: 48 hours after surgery
Secondary outcomes (12)
neutrophil/lymphocyte ratio
neutrophil/lymphocyte ratio
Measured: 12 hours and 24 hours after surgery
platelet/lymphocyte ratio
platelet/lymphocyte ratio
Measured: 12 hours and 24 hours after surgery
Nausea or Vomiting
presence or absence
Measured: during first 24 hours after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Measured: Day 1 after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Measured: Day 2 after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Measured: Day 3 after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Measured: Day 4 after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Measured: Day 5 after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Measured: Day 6 after surgery
total opioid consumption
intravenous milligrams of morphine equivalents
Measured: Day 7 after surgery
Motor Evoked Potential amplitude
Motor Evoked Potentials durring surgery
Measured: up to seven days prior to the correction of scoliosis
Motor Evoked Potential amplitude
Motor Evoked Potentials during surgery
Measured: up to 24 weeks following the correction of scoliosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 May 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomasz Kotwicki, Ph.D., Study director, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938959
- Sponsor's protocol ID
- 3/2023
- Acronym
- ESPB
- Status last verified
- Oct 2023
- First submitted
- 24 May 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT05938959
- Acronym / sponsor ID
- ESPB / 3/2023
- Conditions
- Scoliosis Idiopathic
- Keywords
- pain management, peripheral nerve block, erector spinae plane block, euromonitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 11 Jul 2023 (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.
The study aims to assess the effect of the interfacial plane blocks on the pain level, the course of postoperative rehabilitation, and its anti-inflammatory analgesic effect.
Detailed description
This study evaluates the analgesic efficacy in adolescents of bilevel, bilateral erector spinae plane (ESP) blocks after posterior spinal fusion surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We aim to investigate how ESP blocks, performed under ultrasound guidance at the two vertebral levels, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until the patient is discharged from the hospital. These primary outcome measures will be compared between a treatment group of participants receiving ESP blocks and a control group receiving a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham group | Active comparator | Drug: Sham blockBilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0,9% Normal Saline |
| ESPB group | Active comparator | Drug: ESPBBilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0.2% Ropivacaine (max 2.5mg/kg) |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age 10-18 years old
- pediatric patients who will undergo the surgical correction of idiopathic scoliosis
Key exclusion criteria (6 listed)
- a history of chronic pain (use of gabapentin/pregabalin for > 3 months or opioid use > 1 repeated opioid prescription in the last three months)
- morbid obesity (BMI > 99th percentile)
- previous surgery
- back abnormalities
- infection at block application area
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 |
|---|---|---|
| Sham blockAlso: 0,9% normal salineBilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0,9% normal saline | Drug | Sham group |
| ESPBAlso: 0,2% ropivacaineBilateral ESPB under ultrasound guidance bi-level Th3-6 and Th9-L1(adjusted to the incision line): 0.3-0.5ml/kg 0.2% Ropivacaine (max 2.5mg/kg) | Drug | ESPB group |
Primary outcome
Pain Numerical Rating Scale
Time frame: 30 minutes after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Time frame: 60 minutes after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Time frame: 90 minutes after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Time frame: 120 minutes after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Time frame: 6 hours after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Time frame: 12 hours hours after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Time frame: 24 hours after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Time frame: 48 hours after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
12 secondary outcomes
neutrophil/lymphocyte ratio
Time frame: 12 hours and 24 hours after surgery
platelet/lymphocyte ratio
Time frame: 12 hours and 24 hours after surgery
Nausea or Vomiting
Time frame: during first 24 hours after surgery
total opioid consumption
Time frame: Day 1 after surgery
total opioid consumption
Time frame: Day 2 after surgery
total opioid consumption
Time frame: Day 3 after surgery
total opioid consumption
Time frame: Day 4 after surgery
total opioid consumption
Time frame: Day 5 after surgery
total opioid consumption
Time frame: Day 6 after surgery
total opioid consumption
Time frame: Day 7 after surgery
Motor Evoked Potential amplitude
Time frame: up to seven days prior to the correction of scoliosis
Motor Evoked Potential amplitude
Time frame: up to 24 weeks following the correction of scoliosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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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.
Tomasz Kotwicki, Ph.D. study director
Poznań University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ESPB in people with Scoliosis Idiopathic, run by Poznan University of Medical Sciences at 2 sites in Poland.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magorzata Domagalska, Ph.D. (0048608762068, m.domagalska@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Numerical Rating Scale (time frame: 30 minutes after surgery). The study lists 8 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 13 Oct 2023.