NCT02514343

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

2.3 years

First QC Date

July 30, 2015

Last Update Submit

December 15, 2017

Conditions

Radius Fracture

Keywords

radius fracturemagnesium sulfaterehabilitationbupivacaine

Outcome Measures

Primary Outcomes (1)

  • 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

    At 4 week

Secondary Outcomes (6)

  • Grip strength

    At one minute

  • Wrist mobility

    At 2 weeks

  • Visual Analogue Scale (VAS)

    At minute one

  • Grip strength

    At three minute

  • Wrist mobility

    At 4 week

  • +1 more secondary outcomes

Study Arms (2)

Magnesium sulfate

EXPERIMENTAL

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

Drug: Magnesium Sulfate

Bupivacaine

EXPERIMENTAL

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

Drug: Magnesium SulfateDrug: Bupivacaine

Interventions

Magnesium SulfateDRUG

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

Also known as: Sulfamag, Epsom Salt
BupivacaineMagnesium sulfate
BupivacaineDRUG

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

Also known as: Marcaine, Sensorcaine
Bupivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • distal radius fracture treated with percutaneous pinning and plaster
  • treated in our institution

You may not qualify if:

  • allergy to drugs used
  • drug use or abuse
  • psychiatric disease
  • pulmonal, cardiac, pancreatic, renal or hepatic disease
  • active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 64480, Mexico

Location

Related Publications (6)

  • 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.

    PMID: 25657938RESULT

  • 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.

    PMID: 25995175RESULT

  • 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.

    PMID: 25904273RESULT

  • 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.

    PMID: 23669270RESULT

  • 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.

    PMID: 23121612RESULT

  • 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.

    PMID: 25171663RESULT

MeSH Terms

Conditions

Radius Fractures

Interventions

Magnesium SulfateBupivacaine

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Carlos Acosta-Olivo, MD, PhD

    Universidad Autonoma de Nuevo Leon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 3, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations

ME(1)