Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block
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.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 4
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Wielkopolska
-
Poznan, Wielkopolska, Polska, 61-545
- Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- children scheduled for foot/ankle surgery
- body weight > 5kg
Exclusion Criteria:
- infection at the site of the regional blockade
- coagulation disorders
- immunodeficiency
- ASA= or >4
- steroid medication in regular use
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Komparator placebo: Sham Block
0.2% ropivacaine for popliteal nerve block |
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block
Inne nazwy:
|
|
Aktywny komparator: Dexamethasone
0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block |
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block |
|
Aktywny komparator: Dexmedetomidine
0.5ug/kg dexmedetomidine added to 0.2% ropivacaine for popliteal nerve block |
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
time to the first need of opiate following the procedure
Ramy czasowe: within 48 hours
|
Time after surgery when the patient needs opiate for the first time |
within 48 hours
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Ramy czasowe: 4 hours
|
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. |
4 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Ramy czasowe: 6 hours
|
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. |
6 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Ramy czasowe: 8 hours
|
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. |
8 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Ramy czasowe: 12 hours
|
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. |
12 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Ramy czasowe: 16 hours
|
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. |
16 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Ramy czasowe: 20 hours
|
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. |
20 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Ramy czasowe: 24 hours
|
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. |
24 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Ramy czasowe: 36 hours
|
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. |
36 hours
|
|
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale
Ramy czasowe: 48 hours
|
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. |
48 hours
|
|
Neutrophil-to-lymphocyte ratio
Ramy czasowe: 24 hours after surgery
|
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. |
24 hours after surgery
|
|
Platelet-to-lymphocyte ratio
Ramy czasowe: 48 hours after surgery
|
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. |
48 hours after surgery
|
|
Platelet-to-lymphocyte ratio
Ramy czasowe: 24 hours after surgery
|
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. |
24 hours after surgery
|
|
Time to mobilization
Ramy czasowe: within 48 hours
|
Time after surgery when the patient moves the toe for the first time |
within 48 hours
|
Współpracownicy i badacze
Śledczy
- Krzesło do nauki: Tomasz Kotwicki, Prof dr hab, Poznan University of Medical Sciences
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby układu mięśniowo-szkieletowego
- Rany i urazy
- Procesy patologiczne
- Urazy nóg
- Choroby skórne
- Stany patologiczne, oznaki i objawy
- Choroby skóry i tkanki łącznej
- Urazy kostki
- Choroba
- Choroby stóp
- Urazy stopy
- Związki heterocykliczne, 1-ring
- Związki heterocykliczne
- Azole
- Związki policykliczne
- Imidazoles
- Chemikalia nieorganiczne
- Związki chloru
- Ciąży
- Ciężarne
- Steroidy
- Związki sterownika
- Sterydy, fluorowane
- Ciąży
- Związki sodu
- Chlorki
- Kwas chlorowodorowy
- Deksametazon
- Deksmedetomidyna
- Chlorek sodu
Inne numery identyfikacyjne badania
- 18/2023
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .