Radius FractureNCT02514343
Magnesium Sulfate and Bupivacaine for Rehabilitation After Distal Radius Fractures
A study testing Magnesium Sulfate and Bupivacaine in people with Radius Fracture, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radius Fracture
- What is being tested?
- Magnesium Sulfate and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- distal radius fracture treated with percutaneous pinning and plaster
- treated in our institution
Who cannot join
- allergy to drugs used
- drug use or abuse
- psychiatric disease
- pulmonal, cardiac, pancreatic, renal or hepatic disease
- active infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-articular Infiltration With Magnesium Sulphate and Bupivacaine in Distal Radius Fractures. Randomized, Double-blind Study
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
Read the 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.
- Conditions
- Radius Fracture
- Being tested
- Magnesium Sulfate, Bupivacaine
- Keywords
- radius fracture, magnesium sulfate, rehabilitation, bupivacaine
- Medical subject headings
- Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Also called Sulfamag, Epsom Salt
1ml of 10% magnesium sulfate with 1.5 ml of sterile water
BupivacaineDrug
Also called Marcaine, Sensorcaine
1.5 ml of Bupivacaine 5mg/ml plus 1 ml of 10% magnesium sulfate
| Study group | Role | What they receive |
|---|---|---|
| Magnesium sulfate | Experimental | Will administrate 1 ml of magnesium sulfate 10% and 1.5 mL of sterile water Receives: Drug: Magnesium Sulfate |
| Bupivacaine | Experimental | Will administrate 1 ml of magnesium sulfate 10% and 1.5 ml of bupivacaine (5mg/ml) Receives: Drug: Magnesium Sulfate; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 4 week
Secondary outcomes (6)
Grip strength
Using a hydraulic dynamometer with the patient with elbow in 90º of flexion and forearm in neutral rotation
Measured: At one minute
Wrist mobility
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer
Measured: At 2 weeks
Visual Analogue Scale (VAS)
Measure the maximal pain of the patient
Measured: At minute one
Grip strength
Using a hydraulic dynamometer with the patient with elbow in 90º of flexion and forearm in neutral rotation
Measured: At three minute
Wrist mobility
Mobility in flexion, extension, pronation, supination, cubital and radial deviation using a goniometer
Measured: At 4 week
Visual Analogue Scale
Measurement of the maximal pain of the patient
Measured: At minute three
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon
- Investigators
- Carlos Acosta-Olivo, MD, PhD, Principal investigator, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514343
- Sponsor's protocol ID
- OR15-009
- Status last verified
- Dec 2017
- First submitted
- 30 Jul 2015
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Actually is active this study
Publications
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.
PubMed 25657938Kakar 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.
PubMed 25995175Gunay 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.
PubMed 25904273De 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.
PubMed 23669270Albrecht 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.
PubMed 23121612Pereira 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.
PubMed 25171663
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Infiltration With Magnesium Sulphate and Bupivacaine in Distal Radius Fractures. Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT02514343
- Acronym / sponsor ID
- OR15-009
- Conditions
- Radius Fracture
- Keywords
- radius fracture, magnesium sulfate, rehabilitation, bupivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium sulfate | Experimental | Drug: Magnesium SulfateWill administrate 1 ml of magnesium sulfate 10% and 1.5 mL of sterile water |
| Bupivacaine | Experimental | Drug: Magnesium Sulfate, Drug: BupivacaineWill administrate 1 ml of magnesium sulfate 10% and 1.5 ml of bupivacaine (5mg/ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- distal radius fracture treated with percutaneous pinning and plaster
- treated in our institution
Key exclusion criteria (5 listed)
- allergy to drugs used
- drug use or abuse
- psychiatric disease
- pulmonal, cardiac, pancreatic, renal or hepatic disease
- active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateAlso: Sulfamag, Epsom Salt1ml of 10% magnesium sulfate with 1.5 ml of sterile water | Drug | Bupivacaine, Magnesium sulfate |
| BupivacaineAlso: Marcaine, Sensorcaine1.5 ml of Bupivacaine 5mg/ml plus 1 ml of 10% magnesium sulfate | Drug | Bupivacaine |
Primary outcome
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
6 secondary outcomes
Grip strength
Time frame: At one minute
Wrist mobility
Time frame: At 2 weeks
Visual Analogue Scale (VAS)
Time frame: At minute one
Grip strength
Time frame: At three minute
Wrist mobility
Time frame: At 4 week
Visual Analogue Scale
Time frame: At minute three
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Results publication: PubMed 25657938Meena 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 publication: PubMed 25995175Kakar 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 publication: PubMed 25904273Gunay 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 publication: PubMed 23669270De 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 publication: PubMed 23121612Albrecht 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 publication: PubMed 25171663Pereira 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.
- Individual participant dataSharing planned: Undecided. Actually is active this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Acosta-Olivo, MD, PhD principal investigator
Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate and Bupivacaine in people with Radius Fracture, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Rated Wrist Evaluation (PRWE) (time frame: At 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02514343, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.