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

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).

Study Overview

• Status: Completed
• Conditions: Juvenile Idiopathic Scoliosis, Multiple Sites in Spine
• Intervention / Treatment: Procedure: Erector spinale block (ESP block); Procedure: AG + sham block

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40136
      • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: (AG+ESP) Group; In AG+ ESP Group , the ESP block and the General anesthesia will be performed together in the same patient	Procedure: Erector spinale block (ESP block); The Study has the Objective to analyze the efficacy of the ESP block in spine Surgery (juvenile idiopathic scoliosis) to control perioperative pain
Sham Comparator: AG Group; In AG Group the ESP block wont' be performed, but only a shamed block, realized through 4 skin puncture	Procedure: AG + sham block; General anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First 24 postoperative hours and in particular at 4-8-12-24 hour after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	during surgery
PCA (patient controlled analgesia) boluses of morphine administered and attempted by patients	Patient controlled analgesia electronic pump permits to record all the attempted boluses	the first 48 postoperative hours
total dosage of morphine (total mg) received by the patient	Patient controlled analgesia electronic pump permits to record the all dosage of administered morphine	the first 48 postoperative hours

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): December 11, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: spine surgery; ESP block; pain control; idiopathic scoliosis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: 454/2023/Sper/IOR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No