Magnesium Sulfate and Bupivacaine for Rehabilitation After Distal Radius Fractures
NCT ID: NCT02514343
Last Updated: 2017-12-19
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2015-07-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Magnesium sulfate
Will administrate 1 ml of magnesium sulfate 10% and 1.5 mL of sterile water
Magnesium Sulfate
1ml of 10% magnesium sulfate with 1.5 ml of sterile water
Bupivacaine
Will administrate 1 ml of magnesium sulfate 10% and 1.5 ml of bupivacaine (5mg/ml)
Magnesium Sulfate
1ml of 10% magnesium sulfate with 1.5 ml of sterile water
Bupivacaine
1.5 ml of Bupivacaine 5mg/ml plus 1 ml of 10% magnesium sulfate
Interventions
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Magnesium Sulfate
1ml of 10% magnesium sulfate with 1.5 ml of sterile water
Bupivacaine
1.5 ml of Bupivacaine 5mg/ml plus 1 ml of 10% magnesium sulfate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* treated in our institution
Exclusion Criteria
* drug use or abuse
* psychiatric disease
* pulmonal, cardiac, pancreatic, renal or hepatic disease
* active infection
18 Years
ALL
No
Sponsors
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Universidad Autonoma de Nuevo Leon
OTHER
Responsible Party
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Carlos A Acosta-Olivo
MD, PhD
Principal Investigators
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Carlos Acosta-Olivo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Autonoma de Nuevo Leon
Locations
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Universidad Autonoma de Nuevo Leon
Monterrey, Nuevo León, Mexico
Countries
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References
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Meena S, Sharma P, Sambharia AK, Dawar A. Fractures of distal radius: an overview. J Family Med Prim Care. 2014 Oct-Dec;3(4):325-32. doi: 10.4103/2249-4863.148101.
Kakar S. Clinical Faceoff: Controversies in the Management of Distal Radius Fractures. Clin Orthop Relat Res. 2015 Oct;473(10):3098-104. doi: 10.1007/s11999-015-4335-5. Epub 2015 May 21. No abstract available.
Gunay C, Oken OF, Yavuz OY, Gunay SH, Atalar H. Which modality is the best choice in distal radius fractures treated with two different Kirschner wire fixation and immobilization techniques? Ulus Travma Acil Cerrahi Derg. 2015 Mar;21(2):119-26. doi: 10.5505/tjtes.2015.55938.
De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.
Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.
Pereira DF, Natour J, Machado NP, Furtado RN. Effectiveness of intra-articular injection in wrist joints according to triamcinolone hexacetonide dose in rheumatoid arthritis: a randomized controlled double-blind study. Am J Phys Med Rehabil. 2015 Feb;94(2):131-8. doi: 10.1097/PHM.0000000000000174.
Other Identifiers
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OR15-009
Identifier Type: -
Identifier Source: org_study_id