Clinical Trial: Magnesium Sulfate and Bupivacaine for Rehabilitation After Distal Radius Fractures

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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

Detailed Summary:

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 infiltra
Sponsor: Universidad Autonoma de Nuevo Leon

Current Primary Outcome: Patient Rated Wrist Evaluation (PRWE) [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Universidad Autonoma de Nuevo Leon

Dates:
Date Received: July 30, 2015
Date Started: July 2015
Date Completion: July 2017
Last Updated: October 24, 2016
Last Verified: October 2016