Adolescent Idiopathic Scoliosis (AIS)
Conditions
Keywords
Adolescent idiopathic scoliosis, Erector spinae plane block, ESP block, Dexamethasone, Pediatric anesthesia, Regional anesthesia, Postoperative analgesia, Opioid consumption, Scoliosis surgery, Multimodal analgesia, Dose-response
Brief 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.
Detailed description
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.
Interventions
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).
DRUGPlacebo
0.9% sodium chloride will be administered intravenously as placebo according to randomized treatment allocation.
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | 6 hours after surgery | 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. |
| Cumulative Rescue Fentanyl Consumption | 48 hours after surgery | 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). |
| Number of Rescue Fentanyl Doses | 48 hours after surgery | Number of additional intravenous fentanyl rescue doses administered for inadequate postoperative analgesia during the first 48 hours after surgery. |
| Postoperative Nausea and Vomiting | 48 hours after surgery | Occurrence of postoperative nausea and/or vomiting during the first 48 hours after surgery. The need for rescue antiemetic medication will also be recorded. |
| Perioperative Blood Glucose Concentration | 48 hours | Blood glucose concentration will be measured to assess dexamethasone-associated perioperative hyperglycemia. Glucose concentration will be recorded in mg/dL. |
| Incidence of Adverse Events | 48 hours | 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. |
| Postoperative Opioid-Induced Sedation | 24 hours after surgery | 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. |
Countries
Poland
Contacts
CONTACTMałgorzata Reysner, MD PhD
STUDY_CHAIRMałgorzata Reysner, MD PhD
Poznan University of Medical Sciences
Outcome results
None listed