Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery (ESPB)

October 11, 2023 updated by: Poznan University of Medical Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Poznań, Poland
        • Recruiting
        • Poznan University of Medical Sciences
        • Contact:
    • Wielkopolska
      • Poznań, Wielkopolska, Poland, 61-545
        • Recruiting
        • Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 10-18 years old
  • pediatric patients who will undergo the surgical correction of idiopathic scoliosis

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sham group
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
Drug: Sham block
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
Other Names:
  • 0,9% normal saline
Active Comparator: ESPB group
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)
Drug: ESPB
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)
Other Names:
  • 0,2% ropivacaine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Numerical Rating Scale
Time Frame: 30 minutes after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
30 minutes after surgery
Pain Numerical Rating Scale
Time Frame: 60 minutes after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
60 minutes after surgery
Pain Numerical Rating Scale
Time Frame: 90 minutes after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
90 minutes after surgery
Pain Numerical Rating Scale
Time Frame: 120 minutes after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
120 minutes after surgery
Pain Numerical Rating Scale
Time Frame: 6 hours after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
6 hours after surgery
Pain Numerical Rating Scale
Time Frame: 12 hours hours after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
12 hours hours after surgery
Pain Numerical Rating Scale
Time Frame: 24 hours after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
24 hours after surgery
Pain Numerical Rating Scale
Time Frame: 48 hours after surgery
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
48 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
neutrophil/lymphocyte ratio
Time Frame: 12 hours and 24 hours after surgery
neutrophil/lymphocyte ratio
12 hours and 24 hours after surgery
platelet/lymphocyte ratio
Time Frame: 12 hours and 24 hours after surgery
platelet/lymphocyte ratio
12 hours and 24 hours after surgery
Nausea or Vomiting
Time Frame: during first 24 hours after surgery
presence or absence
during first 24 hours after surgery
total opioid consumption
Time Frame: Day 1 after surgery
intravenous milligrams of morphine equivalents
Day 1 after surgery
total opioid consumption
Time Frame: Day 2 after surgery
intravenous milligrams of morphine equivalents
Day 2 after surgery
total opioid consumption
Time Frame: Day 3 after surgery
intravenous milligrams of morphine equivalents
Day 3 after surgery
total opioid consumption
Time Frame: Day 4 after surgery
intravenous milligrams of morphine equivalents
Day 4 after surgery
total opioid consumption
Time Frame: Day 5 after surgery
intravenous milligrams of morphine equivalents
Day 5 after surgery
total opioid consumption
Time Frame: Day 6 after surgery
intravenous milligrams of morphine equivalents
Day 6 after surgery
total opioid consumption
Time Frame: Day 7 after surgery
intravenous milligrams of morphine equivalents
Day 7 after surgery
Motor Evoked Potential amplitude
Time Frame: up to seven days prior to the correction of scoliosis
Motor Evoked Potentials durring surgery
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
Motor Evoked Potentials during surgery
up to 24 weeks following the correction of scoliosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tomasz Kotwicki, Ph.D., Poznan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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