Ankle DiseasePhase 4NCT06304324
Dexmedetomidine Vs Dexamethasone in Popliteal Nerve Block
A Phase 4 study testing 0.9% Sodium chloride, 0.1mg/kg Dexamethasone and 0.05ug/kg Dexmedetomidine in people with Ankle Disease and Ankle Injuries and Disorders, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Effect of Perineural Dexmedetomidine vs. 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 and Disorders, Foot Injury
- What is being tested?
- 0.9% Sodium chloride, 0.1mg/kg Dexamethasone and 0.05ug/kg Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 6 May 2024to 30 Apr 2025
- 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 foot/ankle 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.
Malgorzata Domalska, PhD contact
Poland1 site, 1 recruiting
- Recruiting
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
Poznan, Wielkopolska, 61-545
Tomasz Kotwicki, Profesor, +48618310157, kckod@ump.edu.pl
About this study
Official title: Perineural Dexmedetomidine Vs Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Effect of Perineural Dexmedetomidine vs. 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 popliteal block for analgesia after pediatric ankle surgery.
After ankle/foot 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 anaesthesia is essential in children due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anaesthetics 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 perineural Dexmedetomidine and Dexamethasone. Group 2 will have Dexamethasone in a 0.1mg/kg dose, and group 2 will have dexmedetomidine in a 0.5 ug/kg dose added to the local anaesthetic in peripheral nerve block.
The investigator's goal is to find which perineural adjuvant, Dexamethasone or dexmedetomidine, covers the need for good pain relief and fast recovery postoperatively.
- Being tested
- 0.9% Sodium chloride, 0.1mg/kg Dexamethasone, 0.05ug/kg Dexmedetomidine
- Medical subject headings
- Ankle Injuries, Disease, 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
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block
0.05ug/kg DexmedetomidineDrug
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block
| Study group | Role | What they receive |
|---|---|---|
| Sham Block | Placebo comparator | 0.2% ropivacaine for popliteal nerve block Receives: Drug: 0.9% Sodium chloride |
| Dexamethasone | Active comparator | 0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block Receives: Drug: 0.1mg/kg Dexamethasone |
| Dexmedetomidine | Active comparator | 0.5ug/kg dexmedetomidine added to 0.2% ropivacaine for popliteal nerve block Receives: Drug: 0.05ug/kg Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to the first need of opiate following the procedure
Time after surgery when the patient needs opiate for the first time
Measured: within 48 hours
Secondary outcomes (13)
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: 4 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: 6 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: 8 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: 12 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: 16 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: 20 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: 24 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: 36 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Measured: 48 hours
Neutrophil-to-lymphocyte ratio
Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample.
Measured: 24 hours after surgery
Platelet-to-lymphocyte ratio
The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions.
Measured: 48 hours after surgery
Platelet-to-lymphocyte ratio
The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions.
Measured: 24 hours after surgery
Time to mobilization
Time after surgery when the patient moves the toe for the first time
Measured: within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start6 May 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
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 chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304324
- Sponsor's protocol ID
- 18/2023
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Perineural Dexmedetomidine Vs Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
- ClinicalTrials.gov ID
- NCT06304324
- Acronym / sponsor ID
- 18/2023
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 12 Mar 2024 (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 Dexmedetomidine vs. 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 popliteal block for analgesia after pediatric ankle surgery.
After ankle/foot 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 anaesthesia is essential in children due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anaesthetics 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 perineural Dexmedetomidine and Dexamethasone. Group 2 will have Dexamethasone in a 0.1mg/kg dose, and group 2 will have dexmedetomidine in a 0.5 ug/kg dose added to the local anaesthetic in peripheral nerve block.
The investigator's goal is to find which perineural adjuvant, Dexamethasone or dexmedetomidine, covers the need for good pain relief and fast recovery postoperatively.
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 |
|---|---|---|
| Sham Block | Placebo comparator | Drug: 0.9% Sodium chloride0.2% ropivacaine for popliteal nerve block |
| Dexamethasone | Active comparator | Drug: 0.1mg/kg Dexamethasone0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block |
| Dexmedetomidine | Active comparator | Drug: 0.05ug/kg Dexmedetomidine0.5ug/kg dexmedetomidine 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 foot/ankle 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 | Sham Block |
| 0.1mg/kg Dexamethasoneadministration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block | Drug | Dexamethasone |
| 0.05ug/kg Dexmedetomidineadministration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block | Drug | Dexmedetomidine |
Primary outcome
time to the first need of opiate following the procedure
Time frame: within 48 hours
Time after surgery when the patient needs opiate for the first time
13 secondary outcomes
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Time frame: 4 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Time frame: 6 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Time frame: 8 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Time frame: 12 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Time frame: 16 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Time frame: 20 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Time frame: 24 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Time frame: 36 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Time frame: 48 hours
Neutrophil-to-lymphocyte ratio
Time frame: 24 hours after surgery
Platelet-to-lymphocyte ratio
Time frame: 48 hours after surgery
Platelet-to-lymphocyte ratio
Time frame: 24 hours after surgery
Time to mobilization
Time frame: within 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
- 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.
Malgorzata Domalska, PhD contact
Tomasz Kotwicki, Prof dr hab 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 Phase 4 study testing 0.9% Sodium chloride, 0.1mg/kg Dexamethasone and 0.05ug/kg Dexmedetomidine in people with Ankle Disease and Ankle 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malgorzata Domagalska, PhD (608762068, m.domagalska@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to the first need of opiate following the procedure (time frame: within 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 21 Jan 2025.