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Magnesium Sulfate and Bupivacaine for Rehabilitation After Distal Radius Fractures

Primary Purpose

Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Magnesium Sulfate
Bupivacaine
Sponsored by
Universidad Autonoma de Nuevo Leon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Fracture focused on measuring radius fracture, magnesium sulfate, rehabilitation, bupivacaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad Autonoma de Nuevo Leon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Magnesium sulfate

Bupivacaine

Arm Description

Will administrate 1 ml of magnesium sulfate 10% and 1.5 mL of sterile water

Will administrate 1 ml of magnesium sulfate 10% and 1.5 ml of bupivacaine (5mg/ml)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Grip strength
Using a hydraulic dynamometer with the patient with elbow in 90º of flexion and forearm in neutral rotation
Wrist mobility
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer
Visual Analogue Scale (VAS)
Measure the maximal pain of the patient
Grip strength
Using a hydraulic dynamometer with the patient with elbow in 90º of flexion and forearm in neutral rotation
Wrist mobility
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer
Visual Analogue Scale
Measurement of the maximal pain of the patient

Full Information

First Posted
July 30, 2015
Last Updated
December 15, 2017
Sponsor
Universidad Autonoma de Nuevo Leon
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1. Study Identification

Unique Protocol Identification Number
NCT02514343
Brief Title
Magnesium Sulfate and Bupivacaine for Rehabilitation After Distal Radius Fractures
Official Title
Intra-articular Infiltration With Magnesium Sulphate and Bupivacaine in Distal Radius Fractures. Randomized, Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Nuevo Leon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fracture
Keywords
radius fracture, magnesium sulfate, rehabilitation, bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium sulfate
Arm Type
Experimental
Arm Description
Will administrate 1 ml of magnesium sulfate 10% and 1.5 mL of sterile water
Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
Will administrate 1 ml of magnesium sulfate 10% and 1.5 ml of bupivacaine (5mg/ml)
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
Sulfamag, Epsom Salt
Intervention Description
1ml of 10% magnesium sulfate with 1.5 ml of sterile water
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine, Sensorcaine
Intervention Description
1.5 ml of Bupivacaine 5mg/ml plus 1 ml of 10% magnesium sulfate
Primary Outcome Measure Information:
Title
Patient Rated Wrist Evaluation (PRWE)
Description
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
Secondary Outcome Measure Information:
Title
Grip strength
Description
Using a hydraulic dynamometer with the patient with elbow in 90º of flexion and forearm in neutral rotation
Time Frame
At one minute
Title
Wrist mobility
Description
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer
Time Frame
At 2 weeks
Title
Visual Analogue Scale (VAS)
Description
Measure the maximal pain of the patient
Time Frame
At minute one
Title
Grip strength
Description
Using a hydraulic dynamometer with the patient with elbow in 90º of flexion and forearm in neutral rotation
Time Frame
At three minute
Title
Wrist mobility
Description
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer
Time Frame
At 4 week
Title
Visual Analogue Scale
Description
Measurement of the maximal pain of the patient
Time Frame
At minute three

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Acosta-Olivo, MD, PhD
Organizational Affiliation
Universidad Autonoma de Nuevo Leon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Autonoma de Nuevo Leon
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64480
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Actually is active this study
Citations:
PubMed Identifier
25657938
Citation
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.
Results Reference
result
PubMed Identifier
25995175
Citation
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.
Results Reference
result
PubMed Identifier
25904273
Citation
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.
Results Reference
result
PubMed Identifier
23669270
Citation
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.
Results Reference
result
PubMed Identifier
23121612
Citation
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.
Results Reference
result
PubMed Identifier
25171663
Citation
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.
Results Reference
result

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Magnesium Sulfate and Bupivacaine for Rehabilitation After Distal Radius Fractures

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