NCT05944393RecruitingNot Applicable

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

Poznan University of Medical Sciences1 site in 1 country50 target enrollmentStarted: September 8, 2022Last updated: July 13, 2023

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Not Applicable
Status: Recruiting
Sponsor
Enrollment: 50
Locations: 1
Primary Endpoint: pain score - 6 hours

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description

Subjects will be randomized to one of two groups with a computer-generated arm assignment. The sealed envelopes will be opened immediately prior to nerve block. One group will receive a ESP block and the other will receive a placebo block. The provider performing the block will not be blinded, however all other members of the care team, the patient, and the investigator collecting data will be blinded to the randomization.

Eligibility Criteria

Ages: 1 Year to 18 Years (Child, Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Patients < 18 years old undergoing scoliosis surgery

Exclusion Criteria

•refusal to participate
•Chronic opioid use
•localized infection

Arms & Interventions

ESB block

Experimental

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.

Intervention: Ropivacaine 0.2% Injectable Solution (Drug)

Placebo block

Experimental

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.

Intervention: Normal saline 0.9% Injectable Solution (Drug)