An interventional study of iv dexamethasone and pn dexamethasone in Hand Injuries and Disorders and Wrist Sprain, sponsored by Poznan University of Medical Sciences. Recruiting at 1 site in Poland. Open to participants aged 3 Months to 16 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Treatment
This clinical trial will evaluate the neurological safety and analgesic effectiveness of dexamethasone administered perineurally or intravenously as an adjuvant to brachial plexus block in children undergoing hand or forearm surgery. Dexamethasone is commonly used to prolong the duration of regional anesthesia, but there is limited evidence on long-term neurological safety, particularly in pediatric patients.
All participants will receive a single-shot brachial plexus block using ropivacaine under ultrasound guidance. Patients will be randomized into one of three treatment groups:
perineural dexamethasone, intravenous dexamethasone, or placebo. The primary objective is to determine whether perineural dexamethasone causes any clinically significant nerve injury compared with intravenous administration or placebo. Neurological function will be assessed clinically and via serum neurofilament light chain (NfL) levels over a 12-month follow-up period.
This study may provide evidence regarding the long-term safety profile of perineural dexamethasone in children and help establish evidence-based dosing and administration guidelines.
Regional anesthesia using brachial plexus block is routinely used for pediatric upper limb surgery, but the long-term neurological safety of perineural dexamethasone remains uncertain. Previous adult studies and early pilot investigations suggest that dexamethasone increases the duration of analgesia and may reduce opioid requirements, but pediatric data remain scarce.
This randomized double-blind placebo-controlled clinical trial will compare three approaches:
perineural dexamethasone, intravenous dexamethasone, placebo. Neurological integrity will be evaluated using structured neurological examinations and serial measurement of serum neurofilament light chain (NfL), a biomarker of peripheral nerve damage. Functional recovery, pain scores, opioid use, and adverse events will also be assessed. Each patient will be followed for 12 months.
The results may guide pediatric regional anesthesia practice and help determine whether perineural dexamethasone is safe with regard to neurologic sequelae.
122 studies on the registry are indexed under Hand Injuries; 35 are open to participants now.
This study's planned enrollment of 150 is above the median of 55 across 97 interventional studies indexed under Hand Injuries.
Browse Hand Injuries studies →Poznan University of Medical Sciences is the lead sponsor of 151 studies on the registry; 41 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brachial plexus block with ropivacaine + dexamethasone IV 0.1 mg/kg (max 8 mg) and perineural 0.9% NaCl.
Drug: iv dexamethasone
Brachial plexus block with ropivacaine + dexamethasone perineurally 0.1 mg/kg (max 4 mg) and IV 0.9% NaCl.
Drug: pn dexamethasone
Brachial plexus block with ropivacaine + 0.9% NaCl both IV and perineurally.
Drug: 0.9%NaCl
Participants in this arm will receive intravenous dexamethasone at a dose of 0.1 mg/kg (maximum 8 mg) administered immediately before the brachial plexus block. A perineural placebo (0.9% normal saline) will be added to the local anesthetic syringe for the nerve block in order to maintain blinding.
Participants in this arm will receive dexamethasone administered perineurally at a dose of 0.1 mg/kg (maximum 4 mg) mixed with the local anesthetic solution for the brachial plexus block. An intravenous placebo (0.9% normal saline) will be administered immediately before the block to maintain blinding.
Participants in this arm will receive placebo both intravenously and perineurally. Normal saline will be added to the local anesthetic solution for the brachial plexus block and administered intravenously in volumes matching the active treatment groups in order to maintain blinding.
Incidence of Persistent Neurological Deficit
Incidence of sensory or motor neurological deficit attributed to the block that persists ≥3 months postoperatively.
Time frame: up to 12 months
Time to First rescue analgesia
Time (in hours) from completion of the brachial plexus block to the first self-reported painful sensation requiring administration of analgesic medication.
Time frame: Within 0-48 hours after surgery.
Total Opioid Consumption
Total cumulative opioid dose administered postoperatively, converted to oral morphine milligram equivalents (MME) and normalized to body weight (mg/kg).
Time frame: 0-48 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Postoperative pain intensity will be assessed in younger children using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. Mean FLACC scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 2 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Postoperative pain intensity will be assessed in younger children using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. Mean FLACC scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 6 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Postoperative pain intensity will be assessed in younger children using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. Mean FLACC scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 12 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Postoperative pain intensity will be assessed in younger children using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. Mean FLACC scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 24 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Postoperative pain intensity will be assessed in younger children using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the most severe pain. Higher scores indicate worse pain. Mean FLACC scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 48 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 2 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 6 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 12 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 24 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Postoperative pain intensity will be assessed in adolescents using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Mean NRS scores will be compared between treatment groups.
Time frame: Post-anesthesia care unit (PACU), 48 hours after surgery.
Adverse Events
Incidence of adverse events potentially related to the nerve block, including postoperative nausea and vomiting (PONV), hematoma, infection, or local anesthetic systemic toxicity (LAST).
Time frame: Up to 30 days after surgery.
Incidence of perioperative hyperglycemia
Incidence of perioperative hyperglycemia, defined as blood glucose concentration \>180 mg/dL (10 mmol/L), measured to evaluate potential systemic metabolic effects of dexamethasone or placebo administration. The proportion of patients who meet the hyperglycemia threshold will be compared between groups.
Time frame: Up to 24 hours after surgery.
Plan to share: Yes — De-identified individual participant data (IPD) that support the findings of this study will be made available to other researchers. Shared data will include baseline characteristics, anesthetic and surgical variables, primary and secondary outcome measures, adverse events, and follow-up assessments. No information that could identify participants will be included.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: IPD will be made available beginning 12 months after publication of the primary study results and will remain available for 5 years thereafter.
Access criteria: Data will be shared with qualified investigators for scientific or clinical research purposes upon reasonable request. Requests will be reviewed by the study investigators. A data sharing agreement may be required.
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Jan 2027, 12 months after the start.
Of 59 non-industry interventional studies with no phase under Hand Injuries, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 26. This study's planned 12 months is below that.
Counting every sponsor, half of 59 studies reached it within 14 months; a quarter within 8 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Dexamethasone · Saline Solution
Poznan University of Medical Sciences →