Wrist DiseasePhase 4NCT05887778
Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery
A Phase 4 study testing Sodium Chloride 0.9% Inj, 0,1mg/kg Dexamethasone and 0,2mg/kg Dexamethasone in people with Wrist Disease and Hand Injuries and Disorders, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of Systematic Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Wrist Disease, Hand Injuries and Disorders
- What is being tested?
- Sodium Chloride 0.9% Inj, 0,1mg/kg Dexamethasone and 0,2mg/kg Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 18 Sep 2023to 10 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children scheduled for hand/wrist surgery
- body weight > 5kg
Who cannot join
- infection at the site of the regional blockade
- coagulation disorders
- immunodeficiency
- ASA= or >4
- steroid medication in regular use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Systematic Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery
Effect of Systematic Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery
Read the detailed description
This study is proposed to explore the effect of systemic Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery.
After hand and wrist surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.
There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.
In this study, investigators compare different doses of systemic Dexamethasone. Before the anesthesia, the patients receive Dexamethasone intravenously. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.2mg/kg.
The investigator's goal is to find a dexamethasone dose that is as low as possible but simultaneously covers the need for good pain relief and fast recovery postoperatively.
- Conditions
- Wrist Disease, Hand Injuries and Disorders
- Being tested
- Sodium Chloride 0.9% Inj, 0,1mg/kg Dexamethasone, 0,2mg/kg Dexamethasone
- 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.
Sodium Chloride 0.9% InjDrug
Also called placebo
administration of 5ml 0,9% sodium chloride - 30 minutes before the supraclavicular brachial plexus block
0,1mg/kg DexamethasoneDrug
Also called small dose
administration of 0,1mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus block
0,2mg/kg DexamethasoneDrug
Also called large dose
administration of 0,2mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| placebo injection | Active comparator | 5ml of 0,9% sodium chloride - before the popliteal nerve block Receives: Drug: Sodium Chloride 0.9% Inj |
| 0,1mg/kg Dexamethasone | Active comparator | 0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block Receives: Drug: 0,1mg/kg Dexamethasone |
| 0,2 mg/kg Dexamethasone | Active comparator | 0,2 mg/kg dexamethasone sodium phosphate - before the popliteal nerve block Receives: Drug: 0,2mg/kg Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
first need of opiate
Time after surgery when the patient needs opiate for the first time
Measured: 48 hours
Secondary outcomes (6)
Opioid Consumption
Total opiate consumption after surgery
Measured: 48 hours
Pain score
children <3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children >3years old NRS (Numerical Rating Scale)
Measured: 4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery
Blood glucose
Blood glucose every 24 hour during hospitalization
Measured: 24 and 48 hours after surgery
NLR
Neutrophil-to-lymphocyte ratio
Measured: 24 and 48 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Measured: 24 and 48 hours after surgery
Mobilisation
Finger movement every 4 hours
Measured: 4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 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 posted5 Jun 2023
- Study start18 Sep 2023
- Primary completion30 Mar 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leszek Romanowski, Prof.dr hab, Study director, Poznań University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887778
- Sponsor's protocol ID
- 9/2023
- Status last verified
- Oct 2023
- First submitted
- 24 May 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Systematic Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery
- ClinicalTrials.gov ID
- NCT05887778
- Acronym / sponsor ID
- 9/2023
- Conditions
- Wrist Disease, Hand Injuries and Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 5 Jun 2023 (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.
Effect of Systematic Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery
Detailed description
This study is proposed to explore the effect of systemic Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery.
After hand and wrist surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.
The safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.
There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.
In this study, investigators compare different doses of systemic Dexamethasone. Before the anesthesia, the patients receive Dexamethasone intravenously. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.2mg/kg.
The investigator's goal is to find a dexamethasone dose that is as low as possible but simultaneously covers the need for good pain relief and fast recovery postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo injection | Active comparator | Drug: Sodium Chloride 0.9% Inj5ml of 0,9% sodium chloride - before the popliteal nerve block |
| 0,1mg/kg Dexamethasone | Active comparator | Drug: 0,1mg/kg Dexamethasone0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block |
| 0,2 mg/kg Dexamethasone | Active comparator | Drug: 0,2mg/kg Dexamethasone0,2 mg/kg dexamethasone sodium phosphate - before the popliteal nerve block |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children scheduled for hand/wrist surgery
- body weight > 5kg
Key exclusion criteria (5 listed)
- infection at the site of the regional blockade
- coagulation disorders
- immunodeficiency
- ASA= or >4
- steroid medication in regular use
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 |
|---|---|---|
| Sodium Chloride 0.9% InjAlso: placeboadministration of 5ml 0,9% sodium chloride - 30 minutes before the supraclavicular brachial plexus block | Drug | placebo injection |
| 0,1mg/kg DexamethasoneAlso: small doseadministration of 0,1mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus block | Drug | 0,1mg/kg Dexamethasone |
| 0,2mg/kg DexamethasoneAlso: large doseadministration of 0,2mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus block | Drug | 0,2 mg/kg Dexamethasone |
Primary outcome
first need of opiate
Time frame: 48 hours
Time after surgery when the patient needs opiate for the first time
6 secondary outcomes
Opioid Consumption
Time frame: 48 hours
Pain score
Time frame: 4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery
Blood glucose
Time frame: 24 and 48 hours after surgery
NLR
Time frame: 24 and 48 hours after surgery
PLR
Time frame: 24 and 48 hours after surgery
Mobilisation
Time frame: 4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
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Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
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Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
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Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
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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. This study is not recruiting at the moment.
Leszek Romanowski, Prof.dr hab study director
Poznań 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 Phase 4 study testing Sodium Chloride 0.9% Inj, 0,1mg/kg Dexamethasone and 0,2mg/kg Dexamethasone in people with Wrist Disease and Hand Injuries and Disorders, 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 11 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first need of opiate (time frame: 48 hours). 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 11 May 2026.