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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

Tracking Information
First Submitted Date  ICMJE January 27, 2012
First Posted Date  ICMJE January 31, 2012
Last Update Posted Date November 20, 2019
Actual Study Start Date  ICMJE January 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
Visual analog scale pain score [ Time Frame: 30 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
Total dose of morphine [ Time Frame: 60 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE Not Provided
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Injuries
  • Pain
  • Emergencies
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 18, 2019)
26
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2012)
66
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01522534
Other Study ID Numbers  ICMJE chra-2009-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Annecy Genevois
Study Sponsor  ICMJE Centre Hospitalier Annecy Genevois
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francois Xavier AGERON, MD Centre Hospitalier Annecy Genevois
PRS Account Centre Hospitalier Annecy Genevois
Verification Date November 2019

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