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

Sponsor

Faculty of Medicine, Sousse (Other)

Overall Status

Completed

CT.gov ID

NCT03597945

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain Due to Trauma	Procedure: lidocaine with epinephrine Procedure: normal saline Procedure: Magnesium sulfate	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants were assigned to one of two groups in parallel for the duration of the studyParticipants were assigned to one of two groups in parallel for the duration of the study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 30, 2015

Actual Primary Completion Date :

Apr 29, 2016

Actual Study Completion Date :

Apr 29, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group Placebo 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 lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture Procedure: normal saline normal saline as adjuvant to lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture
Active Comparator: Group Magnesium 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 lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture Procedure: Magnesium sulfate Magnesium-sulfate as adjuvant to lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture

Arm

Intervention/Treatment

Placebo Comparator: Group Placebo

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

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

Procedure: normal saline

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

Active Comparator: Group Magnesium

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

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

Procedure: Magnesium sulfate

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

Outcome Measures

Primary Outcome Measures

morphine consumption [first 6 hours]
morphine requirements during the first 6 hours (mg)
pain intensity: visual analog scale (VAS) [first 12 hours]
pain intensity during the first 6 hours assessed by the visual analog scale (VAS)

Secondary Outcome Measures

sensitive block duration [first 6 hours]
the duration of the sensitive block (in minutes)
time to the first analgesic request [first 6 hours]
time to the first analgesic request in minutes
side effects occurrence [first 12 hours]
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.