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.
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
- Conditions the study is for
- Juvenile Idiopathic Scoliosis, Multiple Sites in Spine
- 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
- Are there results?
- None posted in the registry
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.
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:
- Verify if the pain measured in the two comparison groups in the first 24 postoperative hours is lower in the ESP Group.
- Verify if the quantity of e.v opioid used intraoperatively, is lower in ESP Group
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| (AG+ESP) Group | Active comparator | In 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 Group | Sham comparator | In 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.
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)
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
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
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.
- First posted9 Jan 2024
- Study start11 Sep 2023
- Primary completion11 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Scoliosis, Multiple Sites in SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane (ESP) Block for Pain Management in Juvenile Idiopathic Scoliosis Surgery: a Single-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06196463
- Acronym / sponsor ID
- 454/2023/Sper/IOR
- Keywords
- idiopathic scoliosis, spine surgery, ESP block, pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Verify if the pain measured in the two comparison groups in the first 24 postoperative hours is lower in the ESP Group.
- Verify if the quantity of e.v opioid used intraoperatively, is lower in ESP Group
- 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.
- 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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| (AG+ESP) Group | Active comparator | Procedure: Erector spinale block (ESP block)In AG+ ESP Group , the ESP block and the General anesthesia will be performed together in the same patient |
| AG Group | Sham comparator | Procedure: AG + sham blockIn AG Group the ESP block wont' be performed, but only a shamed block, realized through 4 skin puncture |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | (AG+ESP) Group |
| AG + sham blockGeneral anesthesia | Procedure or surgery | AG Group |
Primary outcome
Average pain in the two comparison groups the end of surgery).
Time frame: First 24 postoperative hours and in particular at 4-8-12-24 hour after 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.
3 secondary outcomes
Quantity of opioid analgesics used intraoperatively
Time frame: during surgery
PCA (patient controlled analgesia) boluses of morphine administered and attempted by patients
Time frame: the first 48 postoperative hours
total dosage of morphine (total mg) received by the patient
Time frame: the first 48 postoperative hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average pain in the two comparison groups the end of surgery). (time frame: First 24 postoperative hours and in particular at 4-8-12-24 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.