An interventional study of Magnesium Sulfate and Bupivacaine in Radius Fracture, sponsored by Universidad Autonoma de Nuevo Leon. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-19.
Sponsored by Universidad Autonoma de Nuevo Leon · Not applicable, Interventional, and Treatment
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
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 40 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Universidad Autonoma de Nuevo Leon is the lead sponsor of 50 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Will administrate 1 ml of magnesium sulfate 10% and 1.5 mL of sterile water
Drug: Magnesium Sulfate
Will administrate 1 ml of magnesium sulfate 10% and 1.5 ml of bupivacaine (5mg/ml)
Drug: Magnesium Sulfate · Drug: Bupivacaine
1ml of 10% magnesium sulfate with 1.5 ml of sterile water
Also known as: Sulfamag, Epsom Salt
1.5 ml of Bupivacaine 5mg/ml plus 1 ml of 10% magnesium sulfate
Also known as: Marcaine, Sensorcaine
Patient Rated Wrist Evaluation (PRWE)
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
Time frame: At 4 week
Grip strength
Using a hydraulic dynamometer with the patient with elbow in 90º of flexion and forearm in neutral rotation
Time frame: At one minute
Wrist mobility
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer
Time frame: At 2 weeks
Visual Analogue Scale (VAS)
Measure the maximal pain of the patient
Time frame: At minute one
Grip strength
Using a hydraulic dynamometer with the patient with elbow in 90º of flexion and forearm in neutral rotation
Time frame: At three minute
Wrist mobility
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer
Time frame: At 4 week
Visual Analogue Scale
Measurement of the maximal pain of the patient
Time frame: At minute three
Plan to share: Undecided — Actually is active this study
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Universidad Autonoma de Nuevo Leon