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)

November 18, 2019 updated by: Centre Hospitalier Annecy Genevois
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

26

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albertville, France, 73208
        • Centre Hospitalier d'Albertville moutiers
      • Annecy, France, 74374
        • Centre hospitalier de la région d'Annecy
      • Chambery, France, 73000
        • Centre Hospitalier de Chambery
      • Grenoble, France, 38000
        • Centre Hospitalier Universitaire de Grenoble
      • Morzine, France, 74110
        • Centre medical d'Avoriaz
      • Sallanches, France, 74700
        • Centre Hospitalier Sallanches Chamonix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • experimental group
Active Comparator: Morphine
Intravenous Morphine and placebo blind block
Drug: Morphine
Morphine alone with a placebo nerve block
Other Names:
  • control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analog scale pain score
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Total dose of morphine
Time Frame: 60 minutes
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Annecy Genevois

Investigators

  • Principal Investigator: Francois Xavier AGERON, MD, Centre Hospitalier Annecy Genevois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 27, 2012

First Submitted That Met QC Criteria

January 30, 2012

First Posted (Estimate)

January 31, 2012

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • chra-2009-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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