Efficacy and Safety of Hematoma Block Versus Brachial Plexus Block for Closed Reduction of Extra-Articular Distal Radius Fracture: A Prospective Study
EFFICACY AND SAFETY OF HEMATOMA BLOCK VERSUS BRACHIAL PLEXUS BLOCK FOR CLOSED REDUCTION OF EXTRA-ARTICULAR DISTAL RADIUS FRACTURE: A PROSPECTIVE STUDY
Distal radius fractures are one of the most common types of fractures, affecting mostly youngsters and the elderly. Safety, ease of use, affordability, and effectiveness all play a role in analgesia during reduction. This study's goal is to assess how well the Hematoma Block (HB) reduces distal forearm fractures in a developing nation like Nepal. At a tertiary care hospital, a randomized comparative study is used. The individuals with distal forearm fractures that have been radiologically confirmed are enrolled after taking informed consent. When reducing distal forearm fractures, the patients are divided into two groups: Brachial Plexus Block (BPB group) and Hematoma Block group. We note the level of pain before, during, and after reduction using the Visual Analogue Scale (VAS) in both groups. The patient's radiological correction is assessed by Modified Sarmiento Criteria with an immediate post reduction radiograph.
Comparing Hematoma Block and Brachial Plexus Block, we can choose a definitive easy method for reduction that is easy, safe and less time consuming. Hence, the study will provide a guide for commonly occurring distal radius fracture.
Hypotheses of the Study:
Null hypothesis (Ho): There is no difference between feasibility, safety and quality of reduction in the two groups of anesthesia techniques.
Ho: Safety, efficacy and quality of reduction with Hematoma block = Brachial plexus block
Alternate hypothesis (H1): There is a difference between feasibility, safety and quality of reduction in the two groups of anesthesia techniques.
H1: Safety, efficacy and quality of reduction with Hematoma block ≠ Brachial plexus block
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Bagmati
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Dhulikhel, Bagmati, Nepal, 45200
- Dhulikhel Hospital, Kathmandu University Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion criteria:
- Adult male or female patients in the age range of skeletally mature (18 years and above)
- Displaced distal radius fracture, requiring manipulation
- Only extra-articular fractures.
Exclusion Criteria:
- Open fractures (Gustilo Anderson open fracture Type I, II and III), intra-articular fractures, and comminuted fractures.
- Undisplaced distal radial fractures which do not require manipulation.
- Patients who have a history of an adverse reaction to local anesthetics.
- Polytrauma, multiple injuries
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Brachial Plexus Block
Ultrasound-guided regional anesthesia administered by anesthesiology personnel
|
Ultrasound-guided regional anesthesia administered by anesthesiology personnel
|
|
Comparador Ativo: Hematoma Block
Local anesthetic infiltration into the fracture hematoma by an orthopedic surgeon/resident.
|
Local anesthetic infiltration into the fracture hematoma by an orthopedic surgeon/resident.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Severity Assessed by Visual Analogue Scale (VAS)
Prazo: 1 year
|
Pain severity during fracture reduction will be assessed using the Visual Analogue Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain.
Pain scores will be recorded prior to, during, and immediately following fracture reduction.
Higher scores indicate worse pain severity.
|
1 year
|
|
Quality of Fracture Reduction Assessed by Plain Radiographic Parameters
Prazo: 1 year
|
Quality of reduction following fracture manipulation will be assessed using plain radiographs in posteroanterior (PA) and lateral views.
Radiographic parameters include ulnar variance (mm), radial length (mm), radial tilt (degrees), and dorsal/palmar tilt (degrees).
Measurements will be compared between hematoma block and brachial plexus block groups.
|
1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Procedure-Related Complications
Prazo: 1 year
|
Complications related to fracture reduction or anesthesia technique will be recorded during hospital stay and follow-up.
Complications may include neurovascular injury, compartment syndrome, local anesthetic-related adverse events, infection, or failure of reduction.
Outcome will be reported as number and percentage of participants experiencing complications.
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Nho JH, Jang BW, An CY, Yoo JH, Song S, Cho HB, Kim SH, Kim SI, Jung KJ, Kim B. General versus Brachial Plexus Block Anesthesia in Pain Management after Internal Fixation in Patients with Distal Radius Fracture: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Jul 27;19(15):9155. doi: 10.3390/ijerph19159155.
- Lari A, Jarragh A, Alherz M, Nouri A, Behbehani M, Alnusif N. Circumferential periosteal block versus hematoma block for the reduction of distal radius and ulna fractures: a randomized controlled trial. Eur J Trauma Emerg Surg. 2023 Feb;49(1):107-113. doi: 10.1007/s00068-022-02078-8. Epub 2022 Aug 18.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
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Outros números de identificação do estudo
- 43/51
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