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

January 27, 2012
January 30, 2012
January 2012
September 2013   (final data collection date for primary outcome measure)
Visual analog scale pain score [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01522534 on ClinicalTrials.gov Archive Site
Total dose of morphine [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
Not Provided

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Injuries
  • Pain
  • Emergencies
  • Drug: Mepivacaine
    mepivacaine 1% 20 ml corresponding to 200 mg
    Other Name: experimental group
  • Drug: Morphine
    Morphine alone with a placebo nerve block
    Other Name: control group
  • Experimental: Blind block with mepivacaine
    Blind block with mepivacaine and intravenous morphine
    Intervention: Drug: Mepivacaine
  • Active Comparator: Morphine
    Intravenous Morphine and placebo blind block
    Intervention: Drug: Morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
December 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Francois Xavier AGERON, MD 0033450636444 fxageron@ch-annecy.fr
France
 
NCT01522534
chra-2009-001
Yes
Centre Hospitalier de la Région d'Annecy
Centre Hospitalier de la Région d'Annecy
Not Provided
Principal Investigator: Francois Xavier AGERON, MD Centre Hospitalier de la Région d'Annecy
Centre Hospitalier de la Région d'Annecy
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP