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Magnesium-sulfate as Adjuvant in Prehospital Femoral Nerve Block for Patient With Diaphysial Femoral Fracture.

Primary Purpose

Acute Pain Due to Trauma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lidocaine with epinephrine
normal saline
Magnesium sulfate
Sponsored by
Faculty of Medicine, Sousse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain Due to Trauma focused on measuring Magnesium sulfate, lidocaine, femoral nerve block, prehospital, pain

Eligibility Criteria

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

Inclusion Criteria:

  • patients with isolated diaphysial femoral fracture
  • age over 18 years
  • informed and writing consent

Exclusion Criteria:

  • body mass index over 30
  • fracture associated with vascular or sensory disorders
  • cardiovascular diseases
  • hepatic or renal impairments
  • neuromuscular diseases
  • opioids administration before the FNB
  • chronic pain
  • a long-term pain relief treatment
  • pretreatment with calcium or calcium antagonist
  • known allergy to one of the study drugs
  • infection at the injection site
  • open fracture
  • fracture undocumented by the imagery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Group Placebo

    Group Magnesium

    Arm Description

    For patients of this group, the intervention was a femoral nerve block with: 15 ml of lidocaine with epinephrine (300 mg) and 3 ml of normal saline as adjuvant.

    For patients of this group, the intervention was a femoral nerve block with: 15 ml of lidocaine with epinephrine (300 mg) and 3 ml of Magnesium sulfate 15% (450 mg) as adjuvant.

    Outcomes

    Primary Outcome Measures

    morphine consumption
    morphine requirements during the first 6 hours (mg)
    pain intensity: visual analog scale (VAS)
    pain intensity during the first 6 hours assessed by the visual analog scale (VAS)

    Secondary Outcome Measures

    sensitive block duration
    the duration of the sensitive block (in minutes)
    time to the first analgesic request
    time to the first analgesic request in minutes
    side effects occurrence
    the occurrence of side effects such as erythematic, sedation, decrease in average blood pressure, or heart rate of more than 15% of the initial basic value.

    Full Information

    First Posted
    June 25, 2018
    Last Updated
    July 22, 2018
    Sponsor
    Faculty of Medicine, Sousse
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03597945
    Brief Title
    Magnesium-sulfate as Adjuvant in Prehospital Femoral Nerve Block for Patient With Diaphysial Femoral Fracture.
    Official Title
    Magnesium-sulfate as Adjuvant in Prehospital Femoral Nerve Block for Patient With Diaphysial Femoral Fracture: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 30, 2015 (Actual)
    Primary Completion Date
    April 29, 2016 (Actual)
    Study Completion Date
    April 29, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Faculty of Medicine, Sousse

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Prehospital management of traumatic pain is commonly based on morphine while loco-regional analgesia techniques, especially the femoral nerve block (FNB), can be safely and efficiently used. Adjuvants uses can reduce local anesthetic doses and decrease their related risk. The aim of the study was to assess the analgesic effect of Magnesium sulfate (Mg S) when used as adjuvant in prehospital FNB. This is a randomized double-blinded trial conducted in a prehospital medical department of an academic hospital. Patients with isolated diaphysial femoral fracture and eligible to participate were randomized into 2 groups. The Group Placebo had a FNB with 15 ml of lidocaine with epinephrine (300 mg) and 3 ml of normal saline. The Group Magnesium had a FNB with 15 ml of lidocaine with epinephrine (300 mg) and 3 ml of Mg S 15% (450 mg). The FNB was performed according to the WINNIE technique. Primary endpoints were morphine consumption and pain intensity during the first 6 hours. Secondary end-points were the duration of the sensitive block, time to the first analgesic request, side effects occurrence.
    Detailed Description
    After approval by the Research Ethics Board, this randomized double-blinded clinical trial was carried out in the prehospital medical department of a Tunisian teaching hospital over a 3 years period (April 30, 2015 to April 29, 2018). All patients with isolated diaphysial femoral fracture were enrolled. Inclusion criteria were age over 18 years, informed and writing consent. Based on the results of a previous study and targeting a decrease of 1 cm in pain intensity assessed by the visual analogue score (VAS), the sample size was assessed to be at least 22 patients in each study group, considering a threshold of 0.05 and a study power of 90%. Sample size was increased in each group to 25 patients to allow possible dropouts. Included patients randomly received, in a double-blind manner (using computer-generated allocation numbers sealed in brown envelopes), one of two local anesthetic solutions. The control group (Group Placebo) had a FNB with 15 ml of lidocaine with epinephrine 0,005 mg/ml (300 mg) and 3 ml of normal saline. The intervention group (Group Magnesium) had a FNB with 15 ml of lidocaine with epinephrine 0,005 mg/ml (300 mg) and 3 ml of Mg S 15% (450 mg). FNB was performed according to WINNIE technique after rigorous asepsis. Its efficiency was evaluated 15 minutes after by pinprick test. Pain was assessed by visual analog scale (VAS) every 10 minutes for the first hour, then every 60 minutes until the 6th hour after the block. Patients with a VAS > 3 received morphine titration. Primary endpoints were morphine consumption and pain intensity during the first 6 hours. Secondary end-points were the duration of the sensitive block, time to the first analgesic request, the occurrence of side effects (erythematic, sedation, decrease in average blood pressure, or heart rate of more than 15% of the initial basic value).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pain Due to Trauma
    Keywords
    Magnesium sulfate, lidocaine, femoral nerve block, prehospital, pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants were assigned to one of two groups in parallel for the duration of the study
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    For patients of this group, the intervention was a femoral nerve block with: 15 ml of lidocaine with epinephrine (300 mg) and 3 ml of normal saline as adjuvant.
    Arm Title
    Group Magnesium
    Arm Type
    Active Comparator
    Arm Description
    For patients of this group, the intervention was a femoral nerve block with: 15 ml of lidocaine with epinephrine (300 mg) and 3 ml of Magnesium sulfate 15% (450 mg) as adjuvant.
    Intervention Type
    Procedure
    Intervention Name(s)
    lidocaine with epinephrine
    Intervention Description
    lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture
    Intervention Type
    Procedure
    Intervention Name(s)
    normal saline
    Intervention Description
    normal saline as adjuvant to lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture
    Intervention Type
    Procedure
    Intervention Name(s)
    Magnesium sulfate
    Intervention Description
    Magnesium-sulfate as adjuvant to lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture
    Primary Outcome Measure Information:
    Title
    morphine consumption
    Description
    morphine requirements during the first 6 hours (mg)
    Time Frame
    first 6 hours
    Title
    pain intensity: visual analog scale (VAS)
    Description
    pain intensity during the first 6 hours assessed by the visual analog scale (VAS)
    Time Frame
    first 12 hours
    Secondary Outcome Measure Information:
    Title
    sensitive block duration
    Description
    the duration of the sensitive block (in minutes)
    Time Frame
    first 6 hours
    Title
    time to the first analgesic request
    Description
    time to the first analgesic request in minutes
    Time Frame
    first 6 hours
    Title
    side effects occurrence
    Description
    the occurrence of side effects such as erythematic, sedation, decrease in average blood pressure, or heart rate of more than 15% of the initial basic value.
    Time Frame
    first 12 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with isolated diaphysial femoral fracture age over 18 years informed and writing consent Exclusion Criteria: body mass index over 30 fracture associated with vascular or sensory disorders cardiovascular diseases hepatic or renal impairments neuromuscular diseases opioids administration before the FNB chronic pain a long-term pain relief treatment pretreatment with calcium or calcium antagonist known allergy to one of the study drugs infection at the injection site open fracture fracture undocumented by the imagery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed Kahloul, MD
    Organizational Affiliation
    Faculty of Medicine, Sousse
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    10618948
    Citation
    Fawcett WJ, Haxby EJ, Male DA. Magnesium: physiology and pharmacology. Br J Anaesth. 1999 Aug;83(2):302-20. doi: 10.1093/bja/83.2.302.
    Results Reference
    background
    PubMed Identifier
    9805704
    Citation
    Capdevila X, Biboulet P, Bouregba M, Rubenovitch J, Jaber S. Bilateral continuous 3-in-1 nerve blockade for postoperative pain relief after bilateral femoral shaft surgery. J Clin Anesth. 1998 Nov;10(7):606-9. doi: 10.1016/s0952-8180(98)00097-x.
    Results Reference
    result
    PubMed Identifier
    18042893
    Citation
    Schiferer A, Gore C, Gorove L, Lang T, Steinlechner B, Zimpfer M, Kober A. A randomized controlled trial of femoral nerve blockade administered preclinically for pain relief in femoral trauma. Anesth Analg. 2007 Dec;105(6):1852-4, table of contents. doi: 10.1213/01.ane.0000287676.39323.9e.
    Results Reference
    result
    PubMed Identifier
    25535620
    Citation
    Mukherjee K, Das A, Basunia SR, Dutta S, Mandal P, Mukherjee A. Evaluation of Magnesium as an adjuvant in Ropivacaine-induced supraclavicular brachial plexus block: A prospective, double-blinded randomized controlled study. J Res Pharm Pract. 2014 Oct;3(4):123-9. doi: 10.4103/2279-042X.145387.
    Results Reference
    result
    PubMed Identifier
    16835255
    Citation
    Bondok RS, Abd El-Hady AM. Intra-articular magnesium is effective for postoperative analgesia in arthroscopic knee surgery. Br J Anaesth. 2006 Sep;97(3):389-92. doi: 10.1093/bja/ael176. Epub 2006 Jul 11.
    Results Reference
    result
    PubMed Identifier
    30631386
    Citation
    Jebali C, Kahloul M, Hassine N, Jaouadi MA, Ferhi F, Naija W, Chebili N. Magnesium Sulfate as Adjuvant in Prehospital Femoral Nerve Block for a Patient with Diaphysial Femoral Fracture: A Randomized Controlled Trial. Pain Res Manag. 2018 Dec 3;2018:2926404. doi: 10.1155/2018/2926404. eCollection 2018.
    Results Reference
    derived

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