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ESPB: ESP Block for Pediatric Idiopathic Scoliosis Surgery

Sponsor
Poznan University of Medical Sciences (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05938959
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
16.1
Anticipated Duration (Months)
6.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes 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.
Primary Purpose:
Treatment
Official Title:
ESP Block for Pediatric Idiopathic Scoliosis Surgery. A Prospective, Randomized, Double-blinded Clinical Trial
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jul 30, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain Numerical Rating Scale [30 minutes after surgery]

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

    2. Pain Numerical Rating Scale [60 minutes after surgery]

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

    3. Pain Numerical Rating Scale [90 minutes after surgery]

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

    4. Pain Numerical Rating Scale [120 minutes after surgery]

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

    5. Pain Numerical Rating Scale [6 hours after surgery]

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

    6. Pain Numerical Rating Scale [12 hours hours after surgery]

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

    7. Pain Numerical Rating Scale [24 hours after surgery]

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

    8. Pain Numerical Rating Scale [48 hours after surgery]

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

    Secondary Outcome Measures

    1. neutrophil/lymphocyte ratio [12 hours and 24 hours after surgery]

      neutrophil/lymphocyte ratio

    2. platelet/lymphocyte ratio [12 hours and 24 hours after surgery]

      platelet/lymphocyte ratio

    3. Nausea or Vomiting [during first 24 hours after surgery]

      presence or absence

    4. total opioid consumption [Day 1 after surgery]

      intravenous milligrams of morphine equivalents

    5. total opioid consumption [Day 2 after surgery]

      intravenous milligrams of morphine equivalents

    6. total opioid consumption [Day 3 after surgery]

      intravenous milligrams of morphine equivalents

    7. total opioid consumption [Day 4 after surgery]

      intravenous milligrams of morphine equivalents

    8. total opioid consumption [Day 5 after surgery]

      intravenous milligrams of morphine equivalents

    9. total opioid consumption [Day 6 after surgery]

      intravenous milligrams of morphine equivalents

    10. total opioid consumption [Day 7 after surgery]

      intravenous milligrams of morphine equivalents

    11. Motor Evoked Potential amplitude [up to seven days prior to the correction of scoliosis]

      Motor Evoked Potentials durring surgery

    12. Motor Evoked Potential amplitude [up to 24 weeks following the correction of scoliosis]

      Motor Evoked Potentials during surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Poznan University of Medical Sciences Poznań Poland

    Sponsors and Collaborators

    • Poznan University of Medical Sciences

    Investigators

    • Study Director: Tomasz Kotwicki, Ph.D., Poznań University of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Poznan University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05938959
    Other Study ID Numbers:
    • 3/2023
    First Posted:
    Jul 11, 2023
    Last Update Posted:
    Jul 11, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Poznan University of Medical Sciences
    pain management
    peripheral nerve block
    erector spinae plane block
    euromonitoring
    Additional relevant MeSH terms:
    Scoliosis
    Ropivacaine

    Study Results

    No Results Posted as of Jul 11, 2023