Intravenous Dexamethasone for ESP Block Analgesia in Children Undergoing Idiopathic Scoliosis Surgery

NCT07890220 · tracked via the Priya Life Science Poland tracker

Sponsor

Poznan University of Medical Sciences

Phase

Phase 4

Started

2026-11-01

Last updated

2026-10-22

Condition(s) studied

Adolescent Idiopathic Scoliosis (AIS)

Investigational drug(s) / intervention(s)

Dexamethasone (0.1 mg/kg) →Dexamethasone (0.2 mg/kg) →Placebo

Dexamethasone (0.1 mg/kg): Dexamethasone will be administered intravenously as a single perioperative dose according to randomized treatment allocation: 0.1 mg/kg (maximum dose 4 mg).

Dexamethasone (0.2 mg/kg): Dexamethasone will be administered intravenously as a single perioperative dose according to randomized treatment allocation: 0.2 mg/kg (maximum dose 8 mg).

Placebo: 0.9% sodium chloride will be administered intravenously as placebo according to randomized treatment allocation.

Study summary

This randomized, double-blind, placebo-controlled study will evaluate the effect of intravenous dexamethasone on postoperative analgesia in children and adolescents undergoing surgery for idiopathic scoliosis with bilateral erector spinae plane (ESP) blocks.

Participants will be randomly assigned in a 1:1:1 ratio to receive intravenous placebo, dexamethasone 0.1 mg/kg, or dexamethasone 0.2 mg/kg. All participants will receive standardized general anesthesia, bilateral ultrasound-guided ESP blocks, and multimodal postoperative analgesia.

The study will evaluate postoperative opioid requirements and the duration and quality of postoperative analgesia. Secondary outcomes will include postoperative pain intensity, time to first rescue opioid administration, the proportion of participants requiring rescue opioid analgesia, postoperative nausea and vomiting, blood glucose concentrations, and adverse events.

The study aims to determine whether intravenous dexamethasone improves postoperative analgesia following ESP block and whether the analgesic effect differs between the two studied dexamethasone doses.

Eligibility

Sex

ALL

Min age

10 Years

Max age

18 Years

Healthy volunteers

Inclusion Criteria: * Age 10 to 18 years. * Diagnosis of idiopathic scoliosis. * Scheduled for elective surgical correction of scoliosis under general anesthesia with bilateral ultrasound-guided erector spinae plane (ESP) blocks. * American Society of Anesthesiologists (ASA) physical status I-III. * Written informed consent provided by a parent or legal guardian. * Participant assent obtained when developmentally appropriate and in accordance with applicable ethical requirements. Exclusion Criteria: * Known allergy or hypersensitivity to dexamethasone, local anesthetics, fentanyl, or other medications used in the study protocol. * Contraindication to ESP block, including infection at the planned injection site or clinically significant coagulation disorder. * Systemic corticosteroid therapy before surgery that, in the investigator's judgment, could affect study outcomes. * Diabetes mellitus or another clinically significant disorder of glucose metabolism. * Severe hepatic or renal impairment. * Chronic opioid therapy before surgery. * Chronic pain requiring regular analgesic medication. * Previous adverse reaction or clinically significant intolerance to fentanyl. * Participation in another interventional clinical trial that could affect the study outcomes. * Any medical condition that, in the investigator's judgment, could interfere with study procedures, assessment of outcomes, or participant safety.

Primary outcome measure(s)

Cumulative Intravenous Fentanyl Consumption — 48 hours after surgery
Total cumulative dose of intravenous fentanyl administered during the first 48 hours after surgery, including continuous infusion and any additional rescue doses. Fentanyl consumption will be normalized to body weight and expressed as micrograms per kilogram (µg/kg).

Trial sites (1)

Facility	City	Region	Status
Poznan University of Medical Sciences	Poznan	Poland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07890220 on ClinicalTrials.gov ↗ ← All trials in Poland