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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Bagmati
-
Dhulikhel, Bagmati, Népal, 45200
- Dhulikhel Hospital, Kathmandu University Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Brachial Plexus Block
Ultrasound-guided regional anesthesia administered by anesthesiology personnel
|
Ultrasound-guided regional anesthesia administered by anesthesiology personnel
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain Severity Assessed by Visual Analogue Scale (VAS)
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Procedure-Related Complications
Délai: 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
|
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 43/51
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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