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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01522534
Recruitment Status : Unknown
Verified January 2012 by Centre Hospitalier de la Région d'Annecy.
Recruitment status was:  Recruiting
First Posted : January 31, 2012
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):
Centre Hospitalier de la Région d'Annecy

Brief Summary:
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 or disease Intervention/treatment Phase
Injuries Pain Emergencies Drug: Mepivacaine Drug: Morphine Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Visual analog scale pain score [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Total dose of morphine [ Time Frame: 60 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01522534

Contact: Francois Xavier AGERON, MD 0033450636444

Centre Hospitalier d'Albertville moutiers Recruiting
Albertville, France, 73208
Contact: Damien Venchiarutti, MD    0033479895599   
Principal Investigator: Damien Venchiarutti, MD         
Centre Hospitalier de la Region d'Annecy Recruiting
Annecy, France, 74374
Contact: Francois-Xavier AGERON, MD    0033450636444   
Principal Investigator: Francois Xavier AGERON, MD         
Centre Hospitalier de Chambéry Recruiting
Chambery, France, 73000
Contact: Stephane Bare, MD    0033479965050   
Principal Investigator: stephane Bare, MD         
Centre Hospitalier Universitaire de GRENOBLE Recruiting
Grenoble, France, 38000
Contact: Katell Berthelot, MD    00334 76 63 42 22   
Principal Investigator: Katell Berthelot, MD         
Centre medical d'Avoriaz Recruiting
Morzine, France, 74110
Contact: bernard Audema, MD    0033450740542   
Principal Investigator: Bernard Audema, MD         
Centre Hospitalier Sallanches Chamonix Not yet recruiting
Sallanches, France, 74700
Contact: frederic Champly    0033450473030   
Principal Investigator: Frederic Champly, MD         
Sponsors and Collaborators
Centre Hospitalier de la Région d'Annecy
Principal Investigator: Francois Xavier AGERON, MD Centre Hospitalier de la Région d'Annecy

Responsible Party: Centre Hospitalier de la Région d'Annecy Identifier: NCT01522534     History of Changes
Other Study ID Numbers: chra-2009-001
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Centre Hospitalier de la Région d'Annecy:
Block, Nerve
Prehospital Emergency Care

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local