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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Dexamethasone + Perineural Placebo | Active Comparator | Brachial plexus block with ropivacaine + dexamethasone IV 0.1 mg/kg (max 8 mg) and perineural 0.9% NaCl. |
|
| Perineural Dexamethasone + Intravenous Placebo | Active Comparator | Brachial plexus block with ropivacaine + dexamethasone perineurally 0.1 mg/kg (max 4 mg) and IV 0.9% NaCl. |
|
| Placebo (IV + Perineural) | Active Comparator | Brachial plexus block with ropivacaine + 0.9% NaCl both IV and perineurally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iv dexamethasone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Persistent Neurological Deficit | Incidence of sensory or motor neurological deficit attributed to the block that persists ≥3 months postoperatively. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 0-48 hours after surgery. |
| Total Opioid Consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malgorzata Reysenr, MD PhD | Contact | 48618738313 | mreysner@ump.edu.pl | |
| Malgorzata Reysner, MD PhD | Contact | 48618738313 | mreysner@ump.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Malgorzata Reysner, MD PhD | Poznan University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Recruiting | Poznan | 62-701 | Poland |
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.
IPD will be made available beginning 12 months after publication of the primary study results and will remain available for 5 years thereafter.
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.
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| ID | Term |
|---|---|
| D006230 | Hand Injuries |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| pn dexamethasone | Drug | 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. |
|
| 0.9%NaCl | Drug | 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. |
|
Total cumulative opioid dose administered postoperatively, converted to oral morphine milligram equivalents (MME) and normalized to body weight (mg/kg).
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | Up to 24 hours after surgery. |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |