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Completed

NCT Number: NCT02514343

Magnesium Sulfate and Bupivacaine for Rehabilitation After Distal Radius Fractures

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 64480, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

1ml of 10% magnesium sulfate with 1.5 ml of sterile water

Other names: Sulfamag, Epsom Salt

Bupivacaine

Drug

1.5 ml of Bupivacaine 5mg/ml plus 1 ml of 10% magnesium sulfate

Other names: Marcaine, Sensorcaine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2015
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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