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Trial record 23 of 71 for:    strength | ( Map: Mexico )

Magnesium Sulfate and Bupivacaine for Rehabilitation After Distal Radius Fractures

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ClinicalTrials.gov Identifier: NCT02514343
Recruitment Status : Completed
First Posted : August 3, 2015
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

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

Condition or disease Intervention/treatment Phase
Radius Fracture Drug: Magnesium Sulfate Drug: Bupivacaine Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intra-articular Infiltration With Magnesium Sulphate and Bupivacaine in Distal Radius Fractures. Randomized, Double-blind Study
Study Start Date : July 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Magnesium sulfate
Will administrate 1 ml of magnesium sulfate 10% and 1.5 mL of sterile water
Drug: Magnesium Sulfate
1ml of 10% magnesium sulfate with 1.5 ml of sterile water
Other Names:
  • Sulfamag
  • Epsom Salt

Experimental: Bupivacaine
Will administrate 1 ml of magnesium sulfate 10% and 1.5 ml of bupivacaine (5mg/ml)
Drug: Magnesium Sulfate
1ml of 10% magnesium sulfate with 1.5 ml of sterile water
Other Names:
  • Sulfamag
  • Epsom Salt

Drug: Bupivacaine
1.5 ml of Bupivacaine 5mg/ml plus 1 ml of 10% magnesium sulfate
Other Names:
  • Marcaine
  • Sensorcaine




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Wrist mobility [ Time Frame: At 2 weeks ]
    Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer

  3. Visual Analogue Scale (VAS) [ Time Frame: At minute one ]
    Measure the maximal pain of the patient

  4. 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

  5. Wrist mobility [ Time Frame: At 4 week ]
    Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer

  6. Visual Analogue Scale [ Time Frame: At minute three ]
    Measurement of the maximal pain of the patient



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514343


Locations
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Mexico
Universidad Autonoma de Nuevo Leon
Monterrey, Nuevo Leon, Mexico, 64480
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
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Principal Investigator: Carlos Acosta-Olivo, MD, PhD Universidad Autonoma de Nuevo Leon

Publications of Results:
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Responsible Party: Carlos A Acosta-Olivo, MD, PhD, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT02514343     History of Changes
Other Study ID Numbers: OR15-009
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Actually is active this study

Keywords provided by Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon:
radius fracture
magnesium sulfate
rehabilitation
bupivacaine

Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Bupivacaine
Magnesium Sulfate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents