Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery

Study Overview
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Brief Summary
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Postoperative pain after scoliosis correction surgery is severe and usually requires long-term intravenous opioid therapy. Local anesthetic options are limited and include intrathecal opioids and epidural analgesia. However, they are rarely used due to side effects and inconsistent efficacy. The investigators describe an opioid-sparing multimodal analgesia regimen with bilateral erector spinae plane blocks.

Detailed Description
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Posterior spinal fusion for scoliosis correction is extremely painful and usually requires long-term, high-dose opioid use for adequate perioperative analgesia. Neuromonitoring, i.e., motor-evoked and somatosensory-evoked potentials (SSEPs), are the current gold standard for preventing neurological damage. Local anesthesia is essential to multimodal analgesia, but options are limited. Intrathecal or epidural opioid injections of local anesthetics have been reported but are rarely used due to logistical complexity, side effects, and inconsistent analgesic efficacy. The erector spinae plane (ESP) block was first described in 2016 for thoracic neuropathic pain. It is a new interfacial plane technique. Easy to perform on patients without spinal deformities. It was successfully used for surgery in adults. However, even with ultrasound guidance, identifying bone markers in scoliosis patients is challenging. The investigators will treat patients for scoliosis with single-shot bilateral ESP blocks. The investigators aim to provide effective perioperative pain control and achieve intraoperative hemodynamic stability without compromising neuromonitoring.

Official Title
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Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery

Conditions
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Scoliosis, Regional Anesthesia, Pediatric Anesthesia, Orthopedic Disorder of Spine

Intervention / Treatment
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* Drug: Ropivacaine 0.2% Injectable Solution
* Drug: Normal saline 0.9% Injectable Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients < 18 years old undergoing scoliosis surgery Exclusion Criteria: refusal to participate > 18 yo Chronic opioid use localized infection

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: after being informed about the study and potential risks. All patients giving written consent will be randomized in a double-blind manner into 2 groups each one containing 25 patients, ESP group (n =25 ): The patients will receive Erector Spine Plane Block (ESP Block) after induction of general anesthesia. Control group (n =25 ): The patients will receive a placebo block after induction of general anesthesia
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESB block<br>Patients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0.2% ropivacaine per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,2% Ropivacaine. The needle is withdrawn, and the needle entry site is wiped clean. | Drug: Ropivacaine 0.2% Injectable Solution<br>* Ultrasound-guided Erector Spine Plane block with 10 mL 0.5% ropivacaine<br>|
| Experimental: Placebo block<br>Patients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0,9% normal saline per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,9% normal saline. The needle is withdrawn, and the needle entry site is wiped clean. | Drug: Normal saline 0.9% Injectable Solution<br>* Ultrasound-guided Erector Spine Plane block with 10 mL 0.9% normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | NRS (numerical rating scale) score (0- no pain to 10 worst pain) | Within 30 minutes of emergence from anesthesia | 
| pain score - 60 minutes | NRS (numerical rating scale) score (0- no pain to 10 worst pain) | Within 60 minutes of emergence from anesthesia | 
| pain score - 90 minutes | NRS (numerical rating scale) score (0- no pain to 10 worst pain) | Within 90 minutes of emergence from anesthesia | 
| pain score - 120 minutes | NRS (numerical rating scale) score (0- no pain to 10 worst pain) | Within 120 minutes of emergence from anesthesia | 
| pain score - 6 hours | NRS (numerical rating scale) score (0- no pain to 10 worst pain) | Within 6 hours of emergence from anesthesia | 
| pain score - 12 hours | NRS (numerical rating scale) score (0- no pain to 10 worst pain) | Within 12 hours of emergence from anesthesia | 
| pain score - 24 hours | NRS (numerical rating scale) score (0- no pain to 10 worst pain) | Within 24 hours of emergence from anesthesia | 
| pain score - 48 hours | NRS (numerical rating scale) score (0- no pain to 10 worst pain) | Within 48 hours of emergence from anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total opioid consumption within first 24 hours | Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is <4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record. | Second day following the procedure | 
| opioid consumption - 48 hours | Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is <4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record. | Within 48 hours of emergence from anesthesia | 
| Nausea and Vomiting | This is a yes/no binary outcome measure defined by administration of any antiemetic drug in the post-anesthesia care unit. | Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (0-48 hours postoperativly) | 
| NLR -12 hours | neutrophil/limphocyte ratio | 12 hours postoperatively | 
| PLR -12 hours | platelet/limphocyte ratio | 12 hours postoperatively | 
| NLR - 24 hours | neutrophil/limphocyte ratio | 12 hours postoperatively | 
| PLR - 24 hours | platelet/limphocyte ratio | 12 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erector spine plane block, neuromonitoring, pain management, multimodal analgesia