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

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.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis; Pediatric Anesthesia; Regional Anesthesia; Orthopedic Disorder of Spine
• Intervention / Treatment: Drug: Ropivacaine 0.2% Injectable Solution; Drug: Normal saline 0.9% Injectable Solution

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Małgorzata Domagalska, PhD; Phone Number: 608762068; Email: m.domagalska@icloud.com
• Study Contact Backup: Name: Małgorzata Domagalska; Email: m.domagalska@icloud.com

Study Locations

• Poland
  • Wielkopolska
    • Poznań, Wielkopolska, Poland, 61-545
      • Recruiting
      • Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
      • Contact: Tomasz Kotwicki, Profesor; Phone Number: +48618310157; Email: kckod@ump.edu.pl

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients < 18 years old undergoing scoliosis surgery

Exclusion Criteria:

• refusal to participate
• > 18 yo
• Chronic opioid use
• localized infection

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESB block; 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; Ultrasound-guided Erector Spine Plane block with 10 mL 0.5% ropivacaine
Experimental: Placebo block; 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; Ultrasound-guided Erector Spine Plane block with 10 mL 0.9% normal saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Małgorzata Domagalska, PhD, Department of Palliative Medicine, University of Medical Sciences; Study Chair: Tomasz Kotwicki, Profesor, Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2022
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: pain management; multimodal analgesia; neuromonitoring; erector spine plane block
• Additional Relevant MeSH Terms: Bone Diseases; Spinal Curvatures; Scoliosis; Musculoskeletal Diseases; Spinal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine
• Other Study ID Numbers: 673/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data presented in this study are available on request from the corresponding author.
• IPD Sharing Time Frame: Data will become available after completing the study- December 2024
• IPD Sharing Access Criteria: The data presented in this study are available on request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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