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 (BPOP)

This study is currently recruiting participants.

Verified January 2012 by Centre Hospitalier de la Région d'Annecy

Sponsor:

Information provided by (Responsible Party):

Centre Hospitalier de la Région d'Annecy

ClinicalTrials.gov Identifier:

NCT01522534

First received: January 27, 2012

Last updated: January 30, 2012

Last verified: January 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Injuries Pain Emergencies	Drug: Mepivacaine Drug: Morphine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Morphine sulfate Mepivacaine Mepivacaine hydrochloride

U.S. FDA Resources

Further study details as provided by Centre Hospitalier de la Région d'Annecy:

Primary Outcome Measures:

Visual analog scale pain score [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total dose of morphine [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	66
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Blind block with mepivacaine Blind block with mepivacaine and intravenous morphine	Drug: Mepivacaine mepivacaine 1% 20 ml corresponding to 200 mg Other Name: experimental group
Active Comparator: Morphine Intravenous Morphine and placebo blind block	Drug: Morphine Morphine alone with a placebo nerve block Other Name: control group

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522534

Contacts

Contact: Francois Xavier AGERON, MD

0033450636444

fxageron@ch-annecy.fr

Locations

France
Centre Hospitalier d'Albertville moutiers	Recruiting
Albertville, France, 73208
Contact: Damien Venchiarutti, MD 0033479895599 damien.venchiarutti@wanadoo.fr
Principal Investigator: Damien Venchiarutti, MD
Centre Hospitalier de la Region d'Annecy	Recruiting
Annecy, France, 74374
Contact: Francois-Xavier AGERON, MD 0033450636444 fxageron@ch-annecy.fr
Principal Investigator: Francois Xavier AGERON, MD
Centre Hospitalier de Chambéry	Recruiting
Chambery, France, 73000
Contact: Stephane Bare, MD 0033479965050 stephane.bare@ch-chambery.fr
Principal Investigator: stephane Bare, MD
Centre Hospitalier Universitaire de GRENOBLE	Recruiting
Grenoble, France, 38000
Contact: Katell Berthelot, MD 00334 76 63 42 22 Kberthelot@chu-grenoble.fr
Principal Investigator: Katell Berthelot, MD
Centre medical d'Avoriaz	Recruiting
Morzine, France, 74110
Contact: bernard Audema, MD 0033450740542 bernard.audema@gmail.com
Principal Investigator: Bernard Audema, MD
Centre Hospitalier Sallanches Chamonix	Not yet recruiting
Sallanches, France, 74700
Contact: frederic Champly 0033450473030 f.champly@ch-sallanches-chamonix.fr
Principal Investigator: Frederic Champly, MD

Sponsors and Collaborators

Centre Hospitalier de la Région d'Annecy

Investigators

Principal Investigator:

Francois Xavier AGERON, MD

Centre Hospitalier de la Région d'Annecy

More Information

No publications provided

Responsible Party:	Centre Hospitalier de la Région d'Annecy
ClinicalTrials.gov Identifier:	NCT01522534 History of Changes
Other Study ID Numbers:	chra-2009-001
Study First Received:	January 27, 2012
Last Updated:	January 30, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier de la Région d'Annecy:

injuries
pain
Block, Nerve
morphine
Prehospital Emergency Care

Additional relevant MeSH terms:

Emergencies
Disease Attributes
Pathologic Processes
Mepivacaine
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013

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