A Phase 4 interventional study of Dexamethasone (0.1 mg/kg) and Dexamethasone (0.2 mg/kg) in Adolescent Idiopathic Scoliosis (AIS), sponsored by Poznan University of Medical Sciences. Not yet recruiting at 1 site in Poland. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Poznan University of Medical Sciences · Phase 4, Interventional, and Treatment
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.
This prospective, randomized, double-blind, placebo-controlled, parallel-group study will investigate the effect of two doses of intravenous dexamethasone on postoperative analgesia in children and adolescents undergoing elective surgical correction of idiopathic scoliosis with bilateral erector spinae plane (ESP) blocks.
Participants will be randomly assigned in a 1:1:1 ratio to one of three study groups: intravenous placebo, intravenous dexamethasone 0.1 mg/kg, or intravenous dexamethasone 0.2 mg/kg. Study medication will be administered intravenously as part of the perioperative anesthetic management. Participants, their parents or legal guardians, clinicians involved in postoperative care and outcome assessment, and investigators analyzing study outcomes will remain blinded to treatment allocation.
All participants will undergo standardized general anesthesia and bilateral ultrasound-guided ESP blocks according to the institutional protocol. Postoperative multimodal analgesia and criteria for administration of rescue opioid analgesia will be standardized across all study groups.
Postoperative opioid consumption will be assessed during the first 48 hours after surgery. Additional outcomes will include time from the end of surgery to the first administration of rescue opioid analgesia, postoperative pain intensity at predefined time points, the proportion of participants requiring rescue opioid analgesia, and postoperative nausea and vomiting. Blood glucose concentrations and adverse events will also be assessed to evaluate the safety of the studied dexamethasone doses.
The study is designed to determine whether intravenous dexamethasone reduces postoperative opioid requirements and improves postoperative analgesia following bilateral ESP block compared with placebo, and to explore whether the analgesic effect differs between dexamethasone doses of 0.1 mg/kg and 0.2 mg/kg.
Poznan University of Medical Sciences is the lead sponsor of 147 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
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.
Drug: Placebo
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.
Drug: Dexamethasone (0.1 mg/kg)
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.
Drug: Dexamethasone (0.2 mg/kg)
Drug page: Dexamethasone
Dexamethasone will be administered intravenously as a single perioperative dose according to randomized treatment allocation: 0.1 mg/kg (maximum dose 4 mg).
Drug page: Dexamethasone
Dexamethasone will be administered intravenously as a single perioperative dose according to randomized treatment allocation: 0.2 mg/kg (maximum dose 8 mg).
0.9% sodium chloride will be administered intravenously as placebo according to randomized treatment allocation.
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).
Time frame: 48 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: 6 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: 12 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: 24 hours after surgery
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: 48 hours after surgery
Cumulative Rescue Fentanyl Consumption
Total cumulative dose of additional intravenous fentanyl administered as rescue analgesia in addition to the continuous fentanyl infusion. Rescue fentanyl consumption will be normalized to body weight and expressed as micrograms per kilogram (µg/kg).
Time frame: 48 hours after surgery
Number of Rescue Fentanyl Doses
Number of additional intravenous fentanyl rescue doses administered for inadequate postoperative analgesia during the first 48 hours after surgery.
Time frame: 48 hours after surgery
Postoperative Nausea and Vomiting
Occurrence of postoperative nausea and/or vomiting during the first 48 hours after surgery. The need for rescue antiemetic medication will also be recorded.
Time frame: 48 hours after surgery
Perioperative Blood Glucose Concentration
Blood glucose concentration will be measured to assess dexamethasone-associated perioperative hyperglycemia. Glucose concentration will be recorded in mg/dL.
Time frame: 48 hours
Perioperative Blood Glucose Concentration
Blood glucose concentration will be measured to assess dexamethasone-associated perioperative hyperglycemia. Glucose concentration will be recorded in mg/dL.
Time frame: 12 hours
Perioperative Blood Glucose Concentration
Blood glucose concentration will be measured to assess dexamethasone-associated perioperative hyperglycemia. Glucose concentration will be recorded in mg/dL.
Time frame: 6 hours
Incidence of Adverse Events
Occurrence of adverse events potentially related to intravenous dexamethasone, bilateral ESP block, or postoperative analgesic treatment, including clinically significant hyperglycemia, neurological complications, local anesthetic systemic toxicity, respiratory depression, or other unexpected adverse events.
Time frame: 48 hours
Postoperative Opioid-Induced Sedation
Postoperative sedation will be assessed using the Pasero Opioid-Induced Sedation Scale (POSS), which categorizes the level of sedation from S (sleeping, easy to arouse) and 1 (awake and alert) to 4 (somnolent, minimal or no response to stimulation). Higher numeric scores indicate greater opioid-induced sedation.
Time frame: 24 hours after surgery
Postoperative Opioid-Induced Sedation
Postoperative sedation will be assessed using the Pasero Opioid-Induced Sedation Scale (POSS), which categorizes the level of sedation from S (sleeping, easy to arouse) and 1 (awake and alert) to 4 (somnolent, minimal or no response to stimulation). Higher numeric scores indicate greater opioid-induced sedation.
Time frame: 48 hours after surgery
Plan to share: Yes — De-identified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning immediately after publication of the main study results and continuing for 5 years after publication.
Access criteria: De-identified individual participant data and supporting documents will be available to researchers who submit a methodologically sound proposal to the corresponding author. Requests will be considered in accordance with applicable ethical, institutional, and data protection requirements.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Dexamethasone
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