Blokada nerwu splotu ramiennego a leczenie standardowe w przypadku zamkniętego nastawienia złamania dalszej części kości promieniowej u dorosłych – badanie BLOCK. krajowe wieloośrodkowe, randomizowane, kontrolowane badanie
The aim of the project is to evaluate the beneficial and harmful effects of an ultrasound-guided brachial plexus nerve block for patients with a distal radius (wrist) fracture in the need of realignment of fractured bone endings without cutting the skin (closed reduction), in comparison to a haematoma block, which is standard care in Denmark.
Every participant will receive one of the following types of anaesthesia for the realignment of the wrist fracture:
- A nerve block of the arm (plexus brachialis block)
- A haematoma block, which is the current standard anaesthesia in the emergency departments.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 4
Kontakty i lokalizacje
Lokalizacje studiów
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Capital Region
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Hillerød, Capital Region, Dania, 3400
- Copenhagen University Hospital - North Zealand Hillerød
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction
Exclusion Criteria:
- Patients who would never qualify for surgery according to local guidelines
- Lack of informed consent
- No Danish Central Person Register (CPR) number
- Allergies to the trial medication
- Distal radius fracture initially deemed to require surgery regardless of the outcome of the closed reduction
- Open fractures (fracture-related wound requiring sutures)
- Other fractures on the same extremity ((NOT including distal ulna fracture(s))
- Bilateral distal radius fractures both requiring closed reduction
- Concomitant medical or surgical condition taking priority over the closed reduction of the distal radius fracture.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Intervention group
Ultrasound-guided brachial plexus nerve block. A total of 30 ml of lidocaine (10 mg/ml) with adrenaline (5 ug/ml) will be administered in multiple injections. |
The block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus block |
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Aktywny komparator: Control group
Haematoma block with local anaesthetics i.e. lidocaine with adrenaline |
Participants will receive no peripheral nerve block and receive a haematoma block, with or without supplemental sedation and/or systemic analgesia for the closed reduction according to local guidelines and clinical practices |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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Skumulowany odsetek pacjentów poddawanych operacji złamania dalszej części kości promieniowej
Ramy czasowe: 90 dni po zamkniętej redukcji
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90 dni po zamkniętej redukcji
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Composite outcome of treatment related complications
Ramy czasowe: 90 days after closed reduction
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loco-regional neurological complications from affected arm, local anaesthetic systemic toxicity, soft tissue injuries (including skin injuries) related to the closed reduction procedure, infection at the site of needle puncture, vessel puncture requiring subsequent treatment (including compression), pneumothorax, allergic reaction, new bone or joint injury (e.g. dislocation or fracture) after the closed reduction and/or pulmonary embolism |
90 days after closed reduction
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Patient Rated Wrist Evaluation (PRWE)
Ramy czasowe: 90 days after closed reduction
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The PRWE is a patient-reported outcome and the PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire |
90 days after closed reduction
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Maximum pain score in the affected wrist during closed reduction(s)
Ramy czasowe: 0-12 hours after the closed reduction
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The pain outcomes are patient-reported as a Numerical Rating Scale (NRS) score on a scale from 0=no pain to 10=worst pain imaginable. If the patient has the closed reduction performed more than one time, the patient will be asked to report the worst pain experienced during all the attempts of a closed reduction. |
0-12 hours after the closed reduction
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Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction
Ramy czasowe: 0 -24 hours after closed reduction
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The radiographic fracture position is evaluated according to the American Academy of Orthopaedic Surgerons (AAOS) guidelines. The fracture position is unacceptable if the fracture has a radial shortening > 3 mm, > 10 degrees dorsal tilt of the articular surface of radius from a perpendicular line on the longitudianal axis of radius or intra-articular displacement or step-off > 2 mm. |
0 -24 hours after closed reduction
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Liczba prób zastosowanych do redukcji zamkniętej
Ramy czasowe: Natychmiast po zamkniętej redukcji
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Natychmiast po zamkniętej redukcji
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Udział poszczególnych powikłań w złożonym wyniku wtórnym
Ramy czasowe: 90 dni po zamkniętej redukcji
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90 dni po zamkniętej redukcji
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Pain at rest in the affected wrist immediately, 90 days, and 12 months after closed reduction
Ramy czasowe: 0-12 hours, 90 days and 12 months after closed reduction
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The pain outcomes are patient-reported as a Numerical Rating Scale (NRS) score on a scale from 0=no pain to 10=worst pain imaginable. |
0-12 hours, 90 days and 12 months after closed reduction
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Maximum pain in the affected wrist within the first 24 hours after closed reduction
Ramy czasowe: 24-36 hours after the closed reduction.
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The pain outcomes are patient-reported as an NRS score on a scale from 0=no pain to 10=worst pain imaginable. |
24-36 hours after the closed reduction.
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Proportion of patients with complex regional pain syndrome (CRPS)
Ramy czasowe: 90 days and 12 months after closed reduction
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CRPS is defined according to the Budapest Criteria |
90 days and 12 months after closed reduction
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Disabilities of the Arm, Shoulder, and Hand (DASH) score
Ramy czasowe: 90 days and 12 months after closed reduction
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DASH-score is calculated from the Danish-validated translation of the DASH questionnaire |
90 days and 12 months after closed reduction
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Patient Rated Wrist Evaluation (PRWE)
Ramy czasowe: 12 months after closed reduction
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PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire |
12 months after closed reduction
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Quality of life (EQ-5D-5L) score
Ramy czasowe: 90 days and 12 months after closed reduction
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The Danish translation of the EQ-5D-5L questionnaire is used and the EQ-5D-5L-score is calculated based on the Danish EQ-5D-5L value set |
90 days and 12 months after closed reduction
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Difficulty of closed reduction of the fracture
Ramy czasowe: Immediately after closed reduction
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The doctor reported ease on a numeric rating scale from 0-10; 0=very easy, 10=very difficult) |
Immediately after closed reduction
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Discomfort related to the anaesthetic procedure
Ramy czasowe: 0-12 hours after closed reduction
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The discomfort is a patient-reported outcome on a numeric rating scale from 0-10; 0=no discomfort, 10=very uncomfortable |
0-12 hours after closed reduction
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Overall satisfaction with the treatment 0 to 24 hours after initiation of the anaesthesia
Ramy czasowe: 24 hours after closed reduction
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The overall satisfaction is a patient-reported outcome on a numeric rating scale from 0-10; 0=very unsatisfied, 10=very satisfied. When evaluating the treatment, the patient is specifically asked to include all elements of the treatment including: the anaesthetic (procedure and following effects), the experience during the closed reduction and the pain and general sensation in the arm/wrist in the first 24 hours after the treatment commencement. |
24 hours after closed reduction
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Proportion of patients with unacceptable radiographic position at first follow-up in the orthopaedic out-patient clinic (typically 10-14 days post-reduction)
Ramy czasowe: 10-14 days after closed reduction
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The radiographic fracture position is evaluated according to the American Academy of Orthopaedic Surgerons (AAOS) guidelines. The fracture position is unacceptable if the fracture has a radial shortening > 3 mm, > 10 degrees dorsal tilt of the articular surface of radius from a perpendicular line on the longitudianal axis of radius or intra-articular displacement or step-off > 2 mm. |
10-14 days after closed reduction
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Proportion of patients having one or more serious adverse events (SAEs), including events related to loss of hand function
Ramy czasowe: Within 90 days after closed reduction
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A SAE is defined as an adverse event that leads to the following incidents:
Surgical reduction of the distal radius fracture, including relevant admission to hospital, will not be catagorised as a SAE. |
Within 90 days after closed reduction
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Proportion of patients having one or more adverse events (AEs)
Ramy czasowe: Within 24 hours after closed reduction
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An AE is defined as any harmful and unintended event, sign, or symptom, that appear during the trial period, regardless of whether this AE is considered related to the treatment or not. |
Within 24 hours after closed reduction
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Cecilie D Harwood, MD, PhD-fellow, Copenhagen University Hospital - North Zealand
- Główny śledczy: Anne-Sofie Jellestad, MD, PhD-fellow, Copenhagen University Hospital - North Zealand
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
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
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CTA no: 2024-512191-35-00
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
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