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Juvenile Idiopathic Scoliosis, Multiple Sites in SpineNCT06196463

Erector Spinae Plane (ESP) Block in Juvenile Idiopathic Scoliosis Surgery

A study testing Erector spinale block (ESP block) in people with Juvenile Idiopathic Scoliosis, Multiple Sites in Spine, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this prospective controlled randomized clinical trial is to compare two intraoperative anesthetic patient management in Spinal surgery for idiopathic scoliosis. In particular in one Group of adolescent patients, the Erector Spinae (ESP) Block (an ultrasound-guided regional anesthesia technique) will be… Read more about this study

Who is it for?
Ages 14 to 25 years
What is being tested?
Erector spinale block (ESP block)
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11 participants
Where
1 siteItaly
Study dates
11 Sep 2023to 31 Dec 2024
Phase
Interventional

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 14 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Elective indication for spine surgery for idiopathic scoliosis at the Spinal Surgery Department and Clinic 1 of the Rizzoli Orthopedic Institute.
  • ASA Status 1 - 3
  • BMI<32
  • Expression of assent to informed consent

Who cannot join

  • Patients who have previously undergone spinal procedures or surgery;
  • Age under 14 years
  • Patients on chronic opioid therapy (defined as the use of opioids continuously in the previous 3 months);
  • Neuro-muscular pathologies;
  • Allergy to drugs that are part of the study protocol;
  • Cognitive deficit.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Istituto Ortopedico Rizzoli

    Bologna, BO, 40136

Other trials in Italy

About this study

Official title: Erector Spinae Plane (ESP) Block for Pain Management in Juvenile Idiopathic Scoliosis Surgery: a Single-center, Randomized Controlled Trial

The goal of this prospective controlled randomized clinical trial is to compare two intraoperative anesthetic patient management in Spinal surgery for idiopathic scoliosis. In particular in one Group of adolescent patients, the Erector Spinae (ESP) Block (an ultrasound-guided regional anesthesia technique) will be performed in addition to general anesthesia before surgical incision, while in the other Group the usual care (only General anesthesia, no Application of regional Block) will be applied. The fact that the ESP block acts on the dorsal branches of the spinal nerves, which innervate the paraspinal and vertebral muscles, makes this technique useful in the pain management of spine surgery. The main questions the study aims to answer are:

  1. Verify if the pain measured in the two comparison groups in the first 24 postoperative hours is lower in the ESP Group.
  2. Verify if the quantity of e.v opioid used intraoperatively, is lower in ESP Group
  3. Verify if in ESP Group the Quantity of additional analgesics calculated by self-administered PCA doses of morphine (patient-controlled analgesia) in the first 24 hours postoperatively is lower than those administered in the usual care Group.
  4. Verify if there are some differences between the two studied groups as regard the: Time to resume walking (expressed in hours from post-operative awakening); bowel movement recovery time (expressed in hours from post-operative awakening); Hospitalization time (expressed in days from the date of surgery until discharge).
Read the detailed description

Spinal surgery for idiopathic scoliosis represents one of the most important post-operative pains in terms of severity and frequency. Perioperative locoregional analgesia can contribute to more effective control of perioperative pain. The Erector Spinae (ESP) Block is an interfascial block performed by identifying the erector spinae muscle (erector spinae muscle) lateral to the spine under ultrasound guidance. A needle is then advanced through the muscle until it makes contact with the transverse vertebral process. At this Point the anesthetic is injected generating a sensitive Block. The ESP block is a simpler procedure to perform than an epidural anesthesia with the advantage of reducing the risks of direct spinal damage, epidural hematoma and central nervous system infection. Before entering the operating theater and proceeding with induction and general anesthesia, patients will be placed in a prone, lateral or sitting position and a light sedation together with a local anesthesia of the skin will be performed to make the execution of the ESP block painless. The operator who will perform the anesthetic block or sham block will be different from the one who administer the anesthesia during surgery and awakes the patients. Therefore he/she will be blind to the kind of group which the patients belong to. The ESP block will be performed in patients in the intervention group ("AG+ESP") with 15 ml (2.5 mg/ml) of levobupivacaine bilaterally at the level of the IV-VI and X-XII thoracic vertebra (total dose 150mg). Patients in the placebo group ("AG group") will be given 4 subcutaneous injections with an ultrasound-guided technique of saline solution of 1 ml each bilaterally at the level of the IV-VI and X-XII thoracic vertebra. After having performed the block, all patients will be returned to the supine position and induction of general anesthesia and intubation will be carried out. The anesthetist who will manage the anesthesia during surgery will be unaware of the patient's group and will administer intraoperative opioids in relation to arterial pressure values and heart rate, while postoperative NSAID and opioids (administered through a patient controlled) will be given to the patients of both group in accordance to a designed and similar protocol. In the perioperative periods the total amount of analgesics and opioids, the level of patient pain measured with a VAS (Visual analogue score) score and other parameters like food intake, walking, time to first bowel movements and food intake will be recorded.

This prospective randomized controlled study performed on patient candidates to spinal surgery for juvenile idiopathic scoliosis, aims to verify the safety, efficacy and feasibility of the ESP block as a single injection compared to standard general anesthesia. Similar studies have analyzed the efficacy of ESP block in degenerative spine surgery, but this kind of block have not been studied in a randomized controlled trial since yet in juvenile idiopathic scoliosis.

Being tested
Erector spinale block (ESP block), AG + sham block
Keywords
idiopathic scoliosis, spine surgery, ESP block, pain control
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector spinale block (ESP block)Procedure or surgery

    The Study has the Objective to analyze the efficacy of the ESP block in spine Surgery (juvenile idiopathic scoliosis) to control perioperative pain

  • AG + sham blockProcedure or surgery

    General anesthesia

Study groups in NCT06196463
Study groupRoleWhat they receive
(AG+ESP) GroupActive comparatorIn AG+ ESP Group , the ESP block and the General anesthesia will be performed together in the same patient
Receives: Procedure: Erector spinale block (ESP block)
AG GroupSham comparatorIn AG Group the ESP block wont' be performed, but only a shamed block, realized through 4 skin puncture
Receives: Procedure: AG + sham block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average pain in the two comparison groups the end of surgery).

    This average is analyzed via Visual Analogue Scale (VAS) in the first 24 postoperative hours. the VAS scale measures the extent of pain. The patient is asked to assign a score between 0 and 10 to the pain she is experiencing, considering 0 as no pain and 10 as maximum pain perceived.

    Measured: First 24 postoperative hours and in particular at 4-8-12-24 hour after surgery

Secondary outcomes (3)
  1. Quantity of opioid analgesics used intraoperatively

    This quantity is calculated as average pro/kg of fentanyl and total dose and total dosage of remifentanil and maximum infusion rate at the same concentration

    Measured: during surgery

  2. PCA (patient controlled analgesia) boluses of morphine administered and attempted by patients

    Patient controlled analgesia electronic pump permits to record all the attempted boluses

    Measured: the first 48 postoperative hours

  3. total dosage of morphine (total mg) received by the patient

    Patient controlled analgesia electronic pump permits to record the all dosage of administered morphine

    Measured: the first 48 postoperative hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2024
  2. Study start11 Sep 2023
  3. Primary completion11 Dec 2024
  4. Study completion31 Dec 2024

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The Study is a prospective randomized controlled double blind trial, The enrolment will be made in accordance to a Random Number Generator Program. After signing the informed consent, verifying the inclusion and exclusion criteria and enrolling the patient, a progressive number will be assigned to each patient in the study.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06196463
Sponsor's protocol ID
454/2023/Sper/IOR
Status last verified
Dec 2025
First submitted
12 Dec 2023
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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