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

July 22, 2018 updated by: Mohamed Kahloul, Faculty of Medicine, Sousse

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine consumption
Time Frame: first 6 hours
morphine requirements during the first 6 hours (mg)
first 6 hours
pain intensity: visual analog scale (VAS)
Time Frame: first 12 hours
pain intensity during the first 6 hours assessed by the visual analog scale (VAS)
first 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitive block duration
Time Frame: first 6 hours
the duration of the sensitive block (in minutes)
first 6 hours
time to the first analgesic request
Time Frame: first 6 hours
time to the first analgesic request in minutes
first 6 hours
side effects occurrence
Time Frame: 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.
first 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Medicine, Sousse

Investigators

  • Principal Investigator: Mohamed Kahloul, MD, Faculty of Medicine, Sousse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2015

Primary Completion (Actual)

April 29, 2016

Study Completion (Actual)

April 29, 2018

Study Registration Dates

First Submitted

June 25, 2018

First Submitted That Met QC Criteria

July 22, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 22, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS 1842015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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