Randomized Double Blind Controlled Trial Comparing a Blind Sciatic Nerve Block in the Popliteal Fossa to Intravenous Morphine for Traumatic Severe Acute Pain in the Prehospital Setting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of the study is to determine the efficacity of a simple blind technic of loco regional anaesthesia of the sciatic nerve compared to the gold standard in emergency medecine : the intravenous morphine for treated the severe pain of leg, ankle or foot trauma in the prehospital setting and mountain rescue.

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Detailed Description

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Severe pain due to leg, ankle or foot trauma do not beneficiated of a simple loco regional anaesthesia technic. Loco regional anesthesia is superior to intravenous morphine for treating severe pain and specially during transportation and mobilization of the patient. The purpose of the study is to assessed a new technic of blind sciatic nerve block in the popliteal fossa in the pre hospital setting compared to the intravenous morphine. The blind technic is a modified technic of the classic sciatic nerve block with nerve stimulation.

Conditions

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Injuries Pain Emergencies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Blind block with mepivacaine

Blind block with mepivacaine and intravenous morphine

Group Type EXPERIMENTAL

Mepivacaine

Intervention Type DRUG

mepivacaine 1% 20 ml corresponding to 200 mg

Morphine

Intravenous Morphine and placebo blind block

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine alone with a placebo nerve block

Interventions

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Mepivacaine

mepivacaine 1% 20 ml corresponding to 200 mg

Intervention Type DRUG

Morphine

Morphine alone with a placebo nerve block

Intervention Type DRUG

Other Intervention Names

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experimental group control group

Eligibility Criteria

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Inclusion Criteria

* Severe pain (VAS \> or = 60mm); injuries of the leg, ankle or foot

Exclusion Criteria

* Hypersensitivity to student agents
* Local infection
* Nerve or vascular pathology in the affected limb, coagulation pathology,
* Chronic use of opoids, use of opoids within 6 hours
* Drug addiction
* Pregnancy
* Systolic blood pressure less than 90 mmHg
* Respiratory rate less than 16 per minute
* Glasgow coma scale \< 14.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No