Ankle DiseasePhase 4NCT06086418
Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
A Phase 4 study testing 0.9 % Sodium Chloride, 0.1mg/kg Dexamethasone and 0.05mg/kg Dexamethasone in people with Ankle Disease and Ankle Injuries, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of Perineural Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Ankle Disease, Ankle Injuries, Foot Injury
- What is being tested?
- 0.9 % Sodium Chloride, 0.1mg/kg Dexamethasone and 0.05mg/kg Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 17 Oct 2023to 30 Mar 2024
- 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 Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Effect of Perineural Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot 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 foot and ankle 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 perineural Dexamethasone. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.05mg/kg added to local anesthetic.
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
- Ankle Disease, Ankle Injuries, Foot Injury, Foot Diseases
- Being tested
- 0.9 % Sodium Chloride, 0.1mg/kg Dexamethasone, 0.05mg/kg Dexamethasone
- Medical subject headings
- Ankle Injuries, Foot Injuries, Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9 % Sodium ChlorideDrug
Also called placebo
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block
0.1mg/kg DexamethasoneDrug
Also called large dose
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block
0.05mg/kg DexamethasoneDrug
Also called small dose
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05mg/kg Dexamethasone for the popliteal nerve block
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 0.2% ropivacaine for popliteal nerve block Receives: Drug: 0.9 % Sodium Chloride |
| 0.1mg/kg Dexamethasone | Active comparator | 0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block Receives: Drug: 0.1mg/kg Dexamethasone |
| 0,05mg/kg dexamethasone | Active comparator | 0.05mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block Receives: Drug: 0.05mg/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 hours 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
Toe 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 posted17 Oct 2023
- Study start17 Oct 2023
- Primary completion23 Feb 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle 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, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomasz Kotwicki, Prof.dr hab., Study director, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086418
- Sponsor's protocol ID
- 13/2023
- Status last verified
- Apr 2024
- First submitted
- 11 Oct 2023
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reysner M, Reysner T, Janusz P, Kowalski G, Shadi M, Daroszewski P, Wieczorowska-Tobis K, Kotwicki T. Dexamethasone as a perineural adjuvant to a ropivacaine popliteal sciatic nerve block for pediatric foot surgery: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2025 Dec 5;50(12):970-976. doi: 10.1136/rapm-2024-105694.
PubMed 39209730
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
- ClinicalTrials.gov ID
- NCT06086418
- Acronym / sponsor ID
- 13/2023
- Conditions
- Ankle Disease, Ankle Injuries, Foot Injury, Foot Diseases
- 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
- 17 Oct 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 17 Oct 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 Perineural Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot 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 foot and ankle 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 perineural Dexamethasone. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.05mg/kg added to local anesthetic.
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, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: 0.9 % Sodium Chloride0.2% ropivacaine for popliteal nerve block |
| 0.1mg/kg Dexamethasone | Active comparator | Drug: 0.1mg/kg Dexamethasone0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block |
| 0,05mg/kg dexamethasone | Active comparator | Drug: 0.05mg/kg Dexamethasone0.05mg/kg dexamethasone added to 0.2% ropivacaine for 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 |
|---|---|---|
| 0.9 % Sodium ChlorideAlso: placeboadministration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block | Drug | placebo |
| 0.1mg/kg DexamethasoneAlso: large doseadministration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block | Drug | 0.1mg/kg Dexamethasone |
| 0.05mg/kg DexamethasoneAlso: small doseadministration of 0.5ml/kg of 0.2% ropivacaine with 0.05mg/kg Dexamethasone for the popliteal nerve block | Drug | 0,05mg/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 21 Jan 2025.
- Derived from this study: PubMed 39209730Reysner M, Reysner T, Janusz P, Kowalski G, Shadi M, Daroszewski P, Wieczorowska-Tobis K, Kotwicki T. Dexamethasone as a perineural adjuvant to a ropivacaine popliteal sciatic nerve block for pediatric foot surgery: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2025 Dec 5;50(12):970-976. doi: 10.1136/rapm-2024-105694.
- Individual participant dataSharing planned: No
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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.
Tomasz Kotwicki, Prof.dr hab. study director
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 Phase 4 study testing 0.9 % Sodium Chloride, 0.1mg/kg Dexamethasone and 0.05mg/kg Dexamethasone in people with Ankle Disease and Ankle Injuries, 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 21 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
On the ClinicalTrials.gov record for NCT06086418, which also lists 1 linked publication.
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 21 Jan 2025.