Erector Spinae Plane Block for Pediatric Idiopathic Scoliosis Surgery

NCT05938959 | Unknown Phase 4 DMC

• 1 other identifier: 3/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Scoliosis Idiopathic

Keywords

pain management; peripheral nerve block; erector spinae plane block; euromonitoring

Outcome Measures

Primary Outcomes (8)

• Pain Numerical Rating Scale

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

  30 minutes after surgery

• Pain Numerical Rating Scale

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

  60 minutes after surgery

• Pain Numerical Rating Scale

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

  90 minutes after surgery

• Pain Numerical Rating Scale

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

  120 minutes after surgery

• Pain Numerical Rating Scale

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

  6 hours after surgery

• Pain Numerical Rating Scale

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

  12 hours hours after surgery

• Pain Numerical Rating Scale

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

  24 hours after surgery

• Pain Numerical Rating Scale

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

  48 hours after surgery

Secondary Outcomes (12)

• neutrophil/lymphocyte ratio

  12 hours and 24 hours after surgery

• platelet/lymphocyte ratio

  12 hours and 24 hours after surgery

• Nausea or Vomiting

  during first 24 hours after surgery

• total opioid consumption

  Day 1 after surgery

• total opioid consumption

  Day 2 after surgery

Study Arms (2)

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

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)

Drug: ESPB

Interventions

Sham block DRUG

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

Also known as: 0,9% normal saline

Sham group

ESPB DRUG

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)

Also known as: 0,2% ropivacaine

ESPB group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (2)

Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland

Poznan, Wielkopolska, 61-545, Poland

RECRUITING

Poznan University of Medical Sciences

Poznan, Poland

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomasz Kotwicki, Ph.D.

  Poznań University of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Magorzata Domagalska, Ph.D.

CONTACT

0048608762068; m.domagalska@icloud.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: July 11, 2023
• Study Start: May 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: September 1, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

PL (2)