Hand Injuries and DisordersNCT07474909
Perineural vs Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand Surgery
A study testing iv dexamethasone, pn dexamethasone and 0.9%NaCl in people with Hand Injuries and Disorders and Wrist Sprain, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- Hand Injuries and Disorders, Wrist Sprain
- What is being tested?
- iv dexamethasone, pn dexamethasone and 0.9%NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 10 Dec 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3 months to 16 years
- Scheduled elective hand or forearm surgery under general anesthesia with a brachial plexus block
- ASA physical status I-III
- Planned use of ultrasound-guided regional anesthesia
- Written informed consent from parent(s) or legal guardian and age-appropriate assent from the child
Who cannot join
- Pre-existing neurological disease or peripheral neuropathy
- Preoperative sensory deficit in the operative limb
- Infection at or near the needle insertion site
- Coagulopathy or therapeutic anticoagulation
- Systemic infection or sepsis
- Chronic steroid therapy within 30 days before surgery
Show all 12Show fewer
- Known allergy to ropivacaine or dexamethasone
- Diabetes mellitus
- BMI > 99th percentile for age and sex.
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial within 30 days
- Refusal of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 62-701
Malgorzata Reysner, M.D. Ph.D., +48 61 873 83 03, mreysner@ump.edu.pl
About this study
Official title: Comparison of Perineural Versus Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand and Forearm Surgery: A Randomized Double-Blind Placebo-Controlled Trial With Neurological Safety Evaluation and Neurofilament Light Chain Biomarker Assessment
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Hand Injuries and Disorders, Wrist Sprain
- Being tested
- iv dexamethasone, pn dexamethasone, 0.9%NaCl
- Medical subject headings
- Hand Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iv dexamethasoneDrug
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.
pn dexamethasoneDrug
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%NaClDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: iv dexamethasone |
| 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. Receives: Drug: pn dexamethasone |
| Placebo (IV + Perineural) | Active comparator | Brachial plexus block with ropivacaine + 0.9% NaCl both IV and perineurally. Receives: Drug: 0.9%NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Persistent Neurological Deficit
Incidence of sensory or motor neurological deficit attributed to the block that persists ≥3 months postoperatively.
Measured: up to 12 months
Secondary outcomes (14)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Up to 24 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 posted16 Mar 2026
- Study start10 Dec 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand Injuries and DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malgorzata Reysner, MD PhD, Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474909
- Sponsor's protocol ID
- 12_2025
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 22 May 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 (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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perineural Versus Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand and Forearm Surgery: A Randomized Double-Blind Placebo-Controlled Trial With Neurological Safety Evaluation and Neurofilament Light Chain Biomarker Assessment
- ClinicalTrials.gov ID
- NCT07474909
- Acronym / sponsor ID
- 12_2025
- Conditions
- Hand Injuries and Disorders, Wrist Sprain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous Dexamethasone + Perineural Placebo | Active comparator | Drug: iv dexamethasoneBrachial plexus block with ropivacaine + dexamethasone IV 0.1 mg/kg (max 8 mg) and perineural 0.9% NaCl. |
| Perineural Dexamethasone + Intravenous Placebo | Active comparator | Drug: pn dexamethasoneBrachial plexus block with ropivacaine + dexamethasone perineurally 0.1 mg/kg (max 4 mg) and IV 0.9% NaCl. |
| Placebo (IV + Perineural) | Active comparator | Drug: 0.9%NaClBrachial plexus block with ropivacaine + 0.9% NaCl both IV and perineurally. |
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 3 months to 16 years
- Scheduled elective hand or forearm surgery under general anesthesia with a brachial plexus block
- ASA physical status I-III
- Planned use of ultrasound-guided regional anesthesia
- Written informed consent from parent(s) or legal guardian and age-appropriate assent from the child
Key exclusion criteria (12 listed)
- Pre-existing neurological disease or peripheral neuropathy
- Preoperative sensory deficit in the operative limb
- Infection at or near the needle insertion site
- Coagulopathy or therapeutic anticoagulation
- Systemic infection or sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iv dexamethasoneParticipants 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. | Drug | Intravenous Dexamethasone + Perineural Placebo |
| pn dexamethasoneParticipants 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. | Drug | Perineural Dexamethasone + Intravenous Placebo |
| 0.9%NaClParticipants 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. | Drug | Placebo (IV + Perineural) |
Primary outcome
Incidence of Persistent Neurological Deficit
Time frame: up to 12 months
Incidence of sensory or motor neurological deficit attributed to the block that persists ≥3 months postoperatively.
14 secondary outcomes
Time to First rescue analgesia
Time frame: Within 0-48 hours after surgery.
Total Opioid Consumption
Time frame: 0-48 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Time frame: Post-anesthesia care unit (PACU), 2 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Time frame: Post-anesthesia care unit (PACU), 6 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Time frame: Post-anesthesia care unit (PACU), 12 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Time frame: Post-anesthesia care unit (PACU), 24 hours after surgery.
Postoperative pain intensity assessed with the Face, Legs, Activity, Cry, Consolability (FLACC) scale
Time frame: Post-anesthesia care unit (PACU), 48 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Time frame: Post-anesthesia care unit (PACU), 2 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Time frame: Post-anesthesia care unit (PACU), 6 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Time frame: Post-anesthesia care unit (PACU), 12 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Time frame: Post-anesthesia care unit (PACU), 24 hours after surgery.
Postoperative pain intensity assessed with the Numerical Rating Scale (NRS)
Time frame: Post-anesthesia care unit (PACU), 48 hours after surgery.
Adverse Events
Time frame: Up to 30 days after surgery.
Incidence of perioperative hyperglycemia
Time frame: Up to 24 hours after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malgorzata Reysner, MD PhD study chair
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iv dexamethasone, pn dexamethasone and 0.9%NaCl in people with Hand Injuries and Disorders and Wrist Sprain, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malgorzata Reysenr, MD PhD (48618738313, mreysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Persistent Neurological Deficit (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.