Effect of Two Doses of Intravenous Dexamethasone on Postoperative Analgesia After Erector Spinae Plane Block in Children Undergoing Surgery for Idiopathic Scoliosis: A Randomized, Double-Blind, Placebo-Controlled Trial
Sponsor study identifier
interventional
90
1 country
1
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2026
Actual (reported)October 22, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Cumulative Intravenous Fentanyl Consumption
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).
48 hours after surgery
Postoperative Pain Intensity
6 hours after surgery
Postoperative Pain Intensity
12 hours after surgery
Participants will receive intravenous placebo (0.9% sodium chloride) in addition to standardized general anesthesia, bilateral ultrasound-guided erector spinae plane (ESP) blocks, and standardized multimodal postoperative analgesia.
Participants will receive intravenous dexamethasone 0.1 mg/kg, with a maximum dose of 4 mg, in addition to standardized general anesthesia, bilateral ultrasound-guided erector spinae plane (ESP) blocks, and standardized multimodal postoperative analgesia.
Dexamethasone will be administered intravenously as a single perioperative dose according to randomized treatment allocation: 0.1 mg/kg (maximum dose 4 mg).
Dexamethasone will be administered intravenously as a single perioperative dose according to randomized treatment allocation: 0.2 mg/kg (maximum dose 8 mg).
Poznan University of Medical Sciences
Poznan, 62-701, Poland
Małgorzata Reysner, MD PhD
Poznan University of Medical Sciences
Małgorzata Reysner, MD PhD
CONTACT
First Submitted
October 15, 2026
First Posted
October 22, 2026
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 1, 2027
Postoperative Pain Intensity
24 hours after surgery
Postoperative Pain Intensity
48 hours after surgery
Cumulative Rescue Fentanyl Consumption
48 hours after surgery
Participants will receive intravenous dexamethasone 0.2 mg/kg, with a maximum dose of 8 mg, in addition to standardized general anesthesia, bilateral ultrasound-guided erector spinae plane (ESP) blocks, and standardized multimodal postoperative analgesia.
0.9% sodium chloride will be administered intravenously as placebo according to randomized treatment allocation.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-09
De-identified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: