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
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
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
NCT ID
NCT03597945
First Posted
June 25, 2018
Last Updated
July 22, 2018
Sponsor
Faculty of Medicine, Sousse
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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Magnesium-sulfate as Adjuvant in Prehospital Femoral Nerve Block for Patient With Diaphysial Femoral Fracture.
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