Adolescent Idiopathic Scoliosis (AIS)Phase 4NCT07890220
Intravenous Dexamethasone for ESP Block Analgesia in Children Undergoing Idiopathic Scoliosis Surgery
A Phase 4 study testing Dexamethasone (0.1 mg/kg) and Dexamethasone (0.2 mg/kg) in people with Adolescent Idiopathic Scoliosis (AIS), run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- What is being tested?
- Dexamethasone (0.1 mg/kg) and Dexamethasone (0.2 mg/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2026to 1 Jan 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Małgorzata Reysner, MD PhD contact
About this study
Official title: 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
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.
Read more
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Being tested
- Dexamethasone (0.1 mg/kg), Dexamethasone (0.2 mg/kg), Placebo
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (0.1 mg/kg)Drug
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)Drug
Dexamethasone will be administered intravenously as a single perioperative dose according to randomized treatment allocation: 0.2 mg/kg (maximum dose 8 mg).
PlaceboDrug
0.9% sodium chloride will be administered intravenously as placebo according to randomized treatment allocation.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Dexamethasone 0.1 mg/kg | Experimental | 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. Receives: Drug: Dexamethasone (0.1 mg/kg) |
| Dexamethasone 0.2 mg/kg | Experimental | 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. Receives: Drug: Dexamethasone (0.2 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 hours after surgery
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Małgorzata Reysner, MD PhD, Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890220
- Sponsor's protocol ID
- 21/2026
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request.