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

Acute Pain Due to Trauma Clinical Trial

Official title:

Magnesium-sulfate as Adjuvant in Prehospital Femoral Nerve Block for Patient With Diaphysial Femoral Fracture: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597945
• Other study ID #: HS 1842015
• Status: Completed
• Phase: N/A
• Start date: April 30, 2015
• Est. completion date: April 29, 2018

Study information

• Verified date: June 2018
• Source: Faculty of Medicine, Sousse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 29, 2018
• Est. primary completion date: April 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Due to Trauma
• Femoral Fractures

Intervention

Procedure:
• lidocaine with epinephrine
lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture
• normal saline
normal saline as adjuvant to lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture
• Magnesium sulfate
Magnesium-sulfate as adjuvant to lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine, Sousse

References & Publications (5)

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. Epub 2006 Jul 11. — View 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. — View Citation

Fawcett WJ, Haxby EJ, Male DA. Magnesium: physiology and pharmacology. Br J Anaesth. 1999 Aug;83(2):302-20. Review. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption	morphine requirements during the first 6 hours (mg)	first 6 hours
Primary	pain intensity: visual analog scale (VAS)	pain intensity during the first 6 hours assessed by the visual analog scale (VAS)	first 12 hours
Secondary	sensitive block duration	the duration of the sensitive block (in minutes)	first 6 hours
Secondary	time to the first analgesic request	time to the first analgesic request in minutes	first 6 hours
Secondary	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.	first 12 hours