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Magnesium Sulfate and Bupivacaine for Rehabilitation After Distal Radius Fractures

15. december 2017 opdateret af: Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

Intra-articular Infiltration With Magnesium Sulphate and Bupivacaine in Distal Radius Fractures. Randomized, Double-blind Study

This study evaluates the effect of 10% magnesium sulfate in the rehabilitation of the wrist mobility in patients with distal radius fracture treated with percutaneous pinning and plaster

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64480
        • Universidad Autonoma de Nuevo Leon

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Magnesium sulfate
Will administrate 1 ml of magnesium sulfate 10% and 1.5 mL of sterile water
1ml of 10% magnesium sulfate with 1.5 ml of sterile water
Andre navne:
  • Sulfamag
  • Epsom Salt
Eksperimentel: Bupivacaine
Will administrate 1 ml of magnesium sulfate 10% and 1.5 ml of bupivacaine (5mg/ml)
1ml of 10% magnesium sulfate with 1.5 ml of sterile water
Andre navne:
  • Sulfamag
  • Epsom Salt
1.5 ml of Bupivacaine 5mg/ml plus 1 ml of 10% magnesium sulfate
Andre navne:
  • Marcaine
  • Sensorcaine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Rated Wrist Evaluation (PRWE)
Tidsramme: At 4 week
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
At 4 week

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Grip strength
Tidsramme: At one minute
Using a hydraulic dynamometer with the patient with elbow in 90º of flexion and forearm in neutral rotation
At one minute
Wrist mobility
Tidsramme: At 2 weeks
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer
At 2 weeks
Visual Analogue Scale (VAS)
Tidsramme: At minute one
Measure the maximal pain of the patient
At minute one
Grip strength
Tidsramme: At three minute
Using a hydraulic dynamometer with the patient with elbow in 90º of flexion and forearm in neutral rotation
At three minute
Wrist mobility
Tidsramme: At 4 week
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer
At 4 week
Visual Analogue Scale
Tidsramme: At minute three
Measurement of the maximal pain of the patient
At minute three

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Carlos Acosta-Olivo, MD, PhD, Universidad Autonoma de Nuevo Leon

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2015

Primær færdiggørelse (Faktiske)

1. november 2017

Studieafslutning (Faktiske)

1. december 2017

Datoer for studieregistrering

Først indsendt

30. juli 2015

Først indsendt, der opfyldte QC-kriterier

30. juli 2015

Først opslået (Skøn)

3. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. december 2017

Sidst verificeret

1. december 2017

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Radiusbrud

Kliniske forsøg med Magnesium Sulfate

3
Abonner