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 recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Centre Hospitalier de la Région d'Annecy.
Recruitment status was  Recruiting
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
  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:


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
Wounds and Injuries
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 April 16, 2014