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

NCT05944393 | Unknown DMC

• 1 other identifier: 673/22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

erector spine plane block; neuromonitoring; pain management; multimodal analgesia

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (7)

• total opioid consumption within first 24 hours

  Second day following the procedure

• opioid consumption - 48 hours

  Within 48 hours of emergence from anesthesia

• Nausea and Vomiting

  Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (0-48 hours postoperativly)

• NLR -12 hours

  12 hours postoperatively

• PLR -12 hours

  12 hours postoperatively

Study Arms (2)

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.

Drug: Ropivacaine 0.2% Injectable Solution

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.

Drug: Normal saline 0.9% Injectable Solution

Interventions

Ropivacaine 0.2% Injectable Solution DRUG

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

ESB block

Normal saline 0.9% Injectable Solution DRUG

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

Placebo block

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients \< 18 years old undergoing scoliosis surgery

You may not qualify if:

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

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

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

Poznan, Wielkopolska, 61-545, Poland

RECRUITING

MeSH Terms

Conditions

Scoliosis; Agnosia

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Małgorzata Domagalska, PhD

  Department of Palliative Medicine, University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Tomasz Kotwicki, Profesor

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

  STUDY CHAIR

Central Study Contacts

Małgorzata Domagalska, PhD

CONTACT

608762068; m.domagalska@icloud.com

Małgorzata Domagalska

CONTACT

m.domagalska@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: July 13, 2023
• Study Start: September 8, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available after completing the study- December 2024
• Access Criteria: The data presented in this study are available on request from the corresponding author.

Locations

PL (1)