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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)

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ClinicalTrials.gov Identifier: NCT01522534
Recruitment Status : Terminated (not enough inclusions)
First Posted : January 31, 2012
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Annecy Genevois

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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, Older Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT01522534


Locations
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France
Centre Hospitalier d'Albertville moutiers
Albertville, France, 73208
Centre Hospitalier de la Region d'Annecy
Annecy, France, 74374
Centre Hospitalier de Chambéry
Chambery, France, 73000
Centre Hospitalier Universitaire de GRENOBLE
Grenoble, France, 38000
Centre medical d'Avoriaz
Morzine, France, 74110
Centre Hospitalier Sallanches Chamonix
Sallanches, France, 74700
Sponsors and Collaborators
Centre Hospitalier Annecy Genevois
Investigators
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Principal Investigator: Francois Xavier AGERON, MD Centre Hospitalier Annecy Genevois
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Responsible Party: Centre Hospitalier Annecy Genevois
ClinicalTrials.gov Identifier: NCT01522534    
Other Study ID Numbers: chra-2009-001
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Keywords provided by Centre Hospitalier Annecy Genevois:
injuries
pain
Block, Nerve
morphine
Prehospital Emergency Care
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Morphine
Mepivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics