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

Primary Purpose

Scoliosis Idiopathic

Status
Recruiting
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Sham block
ESPB
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis Idiopathic focused on measuring pain management, peripheral nerve block, erector spinae plane block, euromonitoring

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, PolandRecruiting
  • Poznan University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sham group

ESPB group

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Pain Numerical Rating Scale
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)

Secondary Outcome Measures

neutrophil/lymphocyte ratio
neutrophil/lymphocyte ratio
platelet/lymphocyte ratio
platelet/lymphocyte ratio
Nausea or Vomiting
presence or absence
total opioid consumption
intravenous milligrams of morphine equivalents
total opioid consumption
intravenous milligrams of morphine equivalents
total opioid consumption
intravenous milligrams of morphine equivalents
total opioid consumption
intravenous milligrams of morphine equivalents
total opioid consumption
intravenous milligrams of morphine equivalents
total opioid consumption
intravenous milligrams of morphine equivalents
total opioid consumption
intravenous milligrams of morphine equivalents
Motor Evoked Potential amplitude
Motor Evoked Potentials durring surgery
Motor Evoked Potential amplitude
Motor Evoked Potentials during surgery

Full Information

First Posted
May 24, 2023
Last Updated
October 11, 2023
Sponsor
Poznan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05938959
Brief Title
Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery
Acronym
ESPB
Official Title
Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery. A Prospective, Randomized, Double-blinded Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poznan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic
Keywords
pain management, peripheral nerve block, erector spinae plane block, euromonitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Patients will be randomly allocated to receive ultrasound-guided ESP block with 0,2% ropivacaine or ESP block with the sham block by computer software 1:1. A researcher who will not be involved in the study will prepare the randomization list and concealed group assignments in consecutively numbered, sealed, opaque envelopes. A consultant anesthesiologist will follow management to open the envelopes shortly before the nerve block performance to reveal the group allocation and perform the procedure according to the assignment. The surgeon, patients, and anesthesia team will be masked to the study group. Group blinding unmasking will only occur once the statistical analysis is complete.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham group
Arm Type
Active Comparator
Arm Description
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
Arm Title
ESPB group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Sham block
Other Intervention Name(s)
0,9% normal saline
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
ESPB
Other Intervention Name(s)
0,2% ropivacaine
Intervention Description
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)
Primary Outcome Measure Information:
Title
Pain Numerical Rating Scale
Description
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time Frame
30 minutes after surgery
Title
Pain Numerical Rating Scale
Description
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time Frame
60 minutes after surgery
Title
Pain Numerical Rating Scale
Description
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time Frame
90 minutes after surgery
Title
Pain Numerical Rating Scale
Description
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time Frame
120 minutes after surgery
Title
Pain Numerical Rating Scale
Description
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time Frame
6 hours after surgery
Title
Pain Numerical Rating Scale
Description
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time Frame
12 hours hours after surgery
Title
Pain Numerical Rating Scale
Description
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time Frame
24 hours after surgery
Title
Pain Numerical Rating Scale
Description
Pain Numerical Rating Scale (0 - no pain, 10 - the worst pain)
Time Frame
48 hours after surgery
Secondary Outcome Measure Information:
Title
neutrophil/lymphocyte ratio
Description
neutrophil/lymphocyte ratio
Time Frame
12 hours and 24 hours after surgery
Title
platelet/lymphocyte ratio
Description
platelet/lymphocyte ratio
Time Frame
12 hours and 24 hours after surgery
Title
Nausea or Vomiting
Description
presence or absence
Time Frame
during first 24 hours after surgery
Title
total opioid consumption
Description
intravenous milligrams of morphine equivalents
Time Frame
Day 1 after surgery
Title
total opioid consumption
Description
intravenous milligrams of morphine equivalents
Time Frame
Day 2 after surgery
Title
total opioid consumption
Description
intravenous milligrams of morphine equivalents
Time Frame
Day 3 after surgery
Title
total opioid consumption
Description
intravenous milligrams of morphine equivalents
Time Frame
Day 4 after surgery
Title
total opioid consumption
Description
intravenous milligrams of morphine equivalents
Time Frame
Day 5 after surgery
Title
total opioid consumption
Description
intravenous milligrams of morphine equivalents
Time Frame
Day 6 after surgery
Title
total opioid consumption
Description
intravenous milligrams of morphine equivalents
Time Frame
Day 7 after surgery
Title
Motor Evoked Potential amplitude
Description
Motor Evoked Potentials durring surgery
Time Frame
up to seven days prior to the correction of scoliosis
Title
Motor Evoked Potential amplitude
Description
Motor Evoked Potentials during surgery
Time Frame
up to 24 weeks following the correction of scoliosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magorzata Domagalska, Ph.D.
Phone
0048608762068
Email
m.domagalska@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Kotwicki, Ph.D.
Organizational Affiliation
Poznań University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
City
Poznań
State/Province
Wielkopolska
ZIP/Postal Code
61-545
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomasz Kotwicki, Profesor
Phone
+48618310157
Email
kckod@ump.edu.pl
Facility Name
Poznan University of Medical Sciences
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grzegorz Kowalski, PhD
Email
gkowalski@ump.edu.pl

12. IPD Sharing Statement

Learn more about this trial

Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery

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