CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
lidocaine with epinephrine +2 moreprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03597945
NCT03597945N/ACompleted

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

Faculty of Medicine, Sousse·interventional·Posted Jul 24, 2018·Updated Jul 24, 2018

In Brief

A clinical study evaluating lidocaine with epinephrine, normal saline, and 1 other intervention for Acute Pain Due to Trauma. Completed, enrolled 48 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 24, 2018
Enrollment StartApr 30, 2015
Primary CompletionApr 29, 2016
Study CompletionApr 29, 2018
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 7.9 years ago

Interventions

lidocaine with epinephrineprocedure

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

normal salineprocedure

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

Magnesium sulfateprocedure

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