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

NCT03597945 | Completed DMC

• 1 other identifier: HS 1842015
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Pain Due to Trauma

Keywords

Magnesium sulfate; lidocaine; femoral nerve block; prehospital; pain

Outcome Measures

Primary Outcomes (2)

• morphine consumption

  morphine requirements during the first 6 hours (mg)

  first 6 hours

• pain intensity: visual analog scale (VAS)

  pain intensity during the first 6 hours assessed by the visual analog scale (VAS)

  first 12 hours

Secondary Outcomes (3)

• sensitive block duration

  first 6 hours

• time to the first analgesic request

  first 6 hours

• side effects occurrence

  first 12 hours

Study Arms (2)

Group Placebo

PLACEBO COMPARATOR

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.

Procedure: lidocaine with epinephrine; Procedure: normal saline

Group Magnesium

ACTIVE COMPARATOR

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.

Procedure: lidocaine with epinephrine; Procedure: Magnesium sulfate

Interventions

lidocaine with epinephrine PROCEDURE

lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture

Group Magnesium; Group Placebo

normal saline PROCEDURE

normal saline as adjuvant to lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture

Group Placebo

Magnesium sulfate PROCEDURE

Magnesium-sulfate as adjuvant to lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture

Group Magnesium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead

Related Publications (6)

• 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.

  PMID: 10618948 BACKGROUND

• 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.

  PMID: 9805704 RESULT

• 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.

  PMID: 18042893 RESULT

• 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.

  PMID: 25535620 RESULT

• 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.

  PMID: 16835255 RESULT

• 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.

  PMID: 30631386 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Epinephrine; Saline Solution; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Mohamed Kahloul, MD

  Faculty of Medicine, Sousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Participants were assigned to one of two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 24, 2018
• Study Start: April 30, 2015
• Primary Completion: April 29, 2016
• Study Completion: April 29, 2018
• Last Updated: July 24, 2018

Record last verified: 2018-06