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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02514343
Magnesium Sulfate and Bupivacaine for Rehabilitation After Distal Radius Fractures
Intra-articular Infiltration With Magnesium Sulphate and Bupivacaine in Distal Radius Fractures. Randomized, Double-blind Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The fractures of distal radius are one of the injuries more frequents in orthopedics. Represent between 8-15% of all bone injuries in adults, and account for up to 20% of all fractures seen in emergency departments.
Despite the frequency of fractures of the distal radius, there is controversy about what is the best way to treat them. The principles of good treatment involving an anatomical reduction with a proper immobilization that keep the reduction. However, the immobilization must be for a brief period to achieve good functional results with a proper rehabilitation, allowing the patient to regain their independence and return to their occupational and daily activities.
One of the treatment employed in the fractures of distal radius is percutaneous pinning and use of rigid immobilization with a plaster for six weeks. Posteriorly we removed the immobilization and percutaneous pins. One of the aspects to take into account is that this procedure is ambulatory and pain in the wrist is an important factor that prevents him from performing a movement joint free, also generating dissatisfaction in the patient.
Recent research has shown that magnesium sulfate reduces postoperative pain applied during the surgical procedure. In addition, it reduces the consumption of opioids and presents no clinical toxicity, for these reasons magnesium sulfate can be considered as an effective adjunct to analgesia postoperative.
The investigators will realize a controlled clinical trial double blind with specific population characteristics, reproducible, prospective, comparative and longitudinal. This study is proposed to study 40 patients, randomly divided into two groups.
Intraarticular infiltration Prior to a detailed explanation of the protocol with signing of the informed consent, be performed intraarticular infiltration with magnesium sulfate alone or in combination with bupivacaine according to the randomization made. The patient will not know the group in which it is assigned, only the doctor who prepare the solution to infiltrate. This procedure will take place after the removal of the immobilization and fixation (plaster and pinning).
With the patient sitting, we realize asepxia with AVAGARD ® for 2 minutes., after this we proceed to intra-articular infiltration of the wrist with sterile technique, will be located by palpation the articular space between structures of the radiocarpal joint. One investigator will infiltrate 1ml of 10% magnesium sulfate with 1.5 ml of sterile water for one group and for the second group will put 1 ml of 10% magnesium sulfate plus 1.5 ml of Bupivacaine 5mg/ml. Posteriorly, another evaluator will perform measurements of range of active motion (ROM) with flexion-extension, radial and ulnar deviation, pronation and supination , as well as grip strength with a hydraulic hand dynamometer (JAMAR ®) and with the visual analog scale (VAS) to assess the pain.
The above mentioned tests shall be the minute one and three after intraarticular infiltration. Then apply PRWE (Patient Rated Wrist Evaluation) and DASH (Disabilities of the Arm, Hand and Shoulder) scales., this scales will apply to two and fourth weeks.
In the sample size calculation, was determined to include 20 patients per group, using a formula of mean differences with a standard deviation of 5 and an expected magnitude of the differences of at least 5 points in the PRWE scale, with a confidence interval of 95, power 80, with a p ˂0. 05 statistically significant β adding the error 20.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Nuevo Leon
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Monterrey, Nuevo Leon, Messico, 64480
- Universidad Autonoma de Nuevo Leon
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- distal radius fracture treated with percutaneous pinning and plaster
- treated in our institution
Exclusion Criteria:
- allergy to drugs used
- drug use or abuse
- psychiatric disease
- pulmonal, cardiac, pancreatic, renal or hepatic disease
- active infection
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Magnesium sulfate
Will administrate 1 ml of magnesium sulfate 10% and 1.5 mL of sterile water
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1ml of 10% magnesium sulfate with 1.5 ml of sterile water
Altri nomi:
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Sperimentale: Bupivacaine
Will administrate 1 ml of magnesium sulfate 10% and 1.5 ml of bupivacaine (5mg/ml)
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1ml of 10% magnesium sulfate with 1.5 ml of sterile water
Altri nomi:
1.5 ml of Bupivacaine 5mg/ml plus 1 ml of 10% magnesium sulfate
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Patient Rated Wrist Evaluation (PRWE)
Lasso di tempo: At 4 week
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Is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.
Developed in 1998 for clinical assessment and is used for specific wrist problems.It is one of the reliable upper extremity outcome instrument
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At 4 week
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Grip strength
Lasso di tempo: At one minute
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Using a hydraulic dynamometer with the patient with elbow in 90º of flexion and forearm in neutral rotation
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At one minute
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Wrist mobility
Lasso di tempo: At 2 weeks
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Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer
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At 2 weeks
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Visual Analogue Scale (VAS)
Lasso di tempo: At minute one
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Measure the maximal pain of the patient
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At minute one
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Grip strength
Lasso di tempo: At three minute
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Using a hydraulic dynamometer with the patient with elbow in 90º of flexion and forearm in neutral rotation
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At three minute
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Wrist mobility
Lasso di tempo: At 4 week
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Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer
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At 4 week
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Visual Analogue Scale
Lasso di tempo: At minute three
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Measurement of the maximal pain of the patient
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At minute three
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Carlos Acosta-Olivo, MD, PhD, Universidad Autonoma de Nuevo Leon
Pubblicazioni e link utili
Pubblicazioni generali
- Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.
- Meena S, Sharma P, Sambharia AK, Dawar A. Fractures of distal radius: an overview. J Family Med Prim Care. 2014 Oct-Dec;3(4):325-32. doi: 10.4103/2249-4863.148101.
- Kakar S. Clinical Faceoff: Controversies in the Management of Distal Radius Fractures. Clin Orthop Relat Res. 2015 Oct;473(10):3098-104. doi: 10.1007/s11999-015-4335-5. Epub 2015 May 21. No abstract available.
- Gunay C, Oken OF, Yavuz OY, Gunay SH, Atalar H. Which modality is the best choice in distal radius fractures treated with two different Kirschner wire fixation and immobilization techniques? Ulus Travma Acil Cerrahi Derg. 2015 Mar;21(2):119-26. doi: 10.5505/tjtes.2015.55938.
- De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.
- Pereira DF, Natour J, Machado NP, Furtado RN. Effectiveness of intra-articular injection in wrist joints according to triamcinolone hexacetonide dose in rheumatoid arthritis: a randomized controlled double-blind study. Am J Phys Med Rehabil. 2015 Feb;94(2):131-8. doi: 10.1097/PHM.0000000000000174.
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Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Ferite e lesioni
- Lesioni al braccio
- Lesioni all'avambraccio
- Fratture, ossa
- Fratture del raggio
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antiaritmici
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Analgesici
- Agenti del sistema sensoriale
- Anestetici
- Modulatori di trasporto a membrana
- Anticonvulsivanti
- Anestetici, Locali
- Ormoni e agenti regolatori del calcio
- Agenti di controllo riproduttivo
- Bloccanti dei canali del calcio
- Agenti tocolitici
- Bupivacaina
- Solfato di magnesio
Altri numeri di identificazione dello studio
- OR15-009
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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