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

NCT ID: NCT05944393

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2023-12-30

Brief Summary

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

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.

Conditions

Scoliosis; Regional Anesthesia; Pediatric Anesthesia; Orthopedic Disorder of Spine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ropivacaine 0.2% Injectable Solution

Intervention Type: DRUG

Ultrasound-guided Erector Spine Plane block with 10 mL 0.5% ropivacaine

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.

Group Type: EXPERIMENTAL

Normal saline 0.9% Injectable Solution

Intervention Type: DRUG

Ultrasound-guided Erector Spine Plane block with 10 mL 0.9% normal saline

Interventions

Ropivacaine 0.2% Injectable Solution

Ultrasound-guided Erector Spine Plane block with 10 mL 0.5% ropivacaine

Intervention Type: DRUG

Normal saline 0.9% Injectable Solution

Ultrasound-guided Erector Spine Plane block with 10 mL 0.9% normal saline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients < 18 years old undergoing scoliosis surgery

Exclusion Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Małgorzata Domagalska, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Palliative Medicine, University of Medical Sciences

Tomasz Kotwicki, Profesor

Role: STUDY_CHAIR

Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences

Locations

Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland

Poznan, Wielkopolska, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Małgorzata Domagalska, PhD

Role: CONTACT

m.domagalska@icloud.com

608762068

Małgorzata Domagalska

Role: CONTACT

m.domagalska@icloud.com

Facility Contacts

Tomasz Kotwicki, Profesor

Role: primary

kckod@ump.edu.pl

+48618310157

Other Identifiers

673/22

Identifier Type: -

Identifier Source: org_study_id