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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)

Primary Purpose

Injuries, Pain, Emergencies

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Mepivacaine
Morphine
Sponsored by
Centre Hospitalier Annecy Genevois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injuries focused on measuring injuries, pain, Block, Nerve, morphine, Prehospital Emergency Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier d'Albertville moutiers
  • Centre Hospitalier de la Region d'Annecy
  • Centre Hospitalier de Chambéry
  • Centre Hospitalier Universitaire de GRENOBLE
  • Centre medical d'Avoriaz
  • Centre Hospitalier Sallanches Chamonix

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blind block with mepivacaine

Morphine

Arm Description

Blind block with mepivacaine and intravenous morphine

Intravenous Morphine and placebo blind block

Outcomes

Primary Outcome Measures

Visual analog scale pain score

Secondary Outcome Measures

Total dose of morphine

Full Information

First Posted
January 27, 2012
Last Updated
November 18, 2019
Sponsor
Centre Hospitalier Annecy Genevois
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1. Study Identification

Unique Protocol Identification Number
NCT01522534
Brief Title
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
Acronym
BPOP
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
not enough inclusions
Study Start Date
January 2012 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Annecy Genevois

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries, Pain, Emergencies
Keywords
injuries, pain, Block, Nerve, morphine, Prehospital Emergency Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blind block with mepivacaine
Arm Type
Experimental
Arm Description
Blind block with mepivacaine and intravenous morphine
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Intravenous Morphine and placebo blind block
Intervention Type
Drug
Intervention Name(s)
Mepivacaine
Other Intervention Name(s)
experimental group
Intervention Description
mepivacaine 1% 20 ml corresponding to 200 mg
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
control group
Intervention Description
Morphine alone with a placebo nerve block
Primary Outcome Measure Information:
Title
Visual analog scale pain score
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Total dose of morphine
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Xavier AGERON, MD
Organizational Affiliation
Centre Hospitalier Annecy Genevois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier d'Albertville moutiers
City
Albertville
ZIP/Postal Code
73208
Country
France
Facility Name
Centre Hospitalier de la Region d'Annecy
City
Annecy
ZIP/Postal Code
74374
Country
France
Facility Name
Centre Hospitalier de Chambéry
City
Chambery
ZIP/Postal Code
73000
Country
France
Facility Name
Centre Hospitalier Universitaire de GRENOBLE
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Centre medical d'Avoriaz
City
Morzine
ZIP/Postal Code
74110
Country
France
Facility Name
Centre Hospitalier Sallanches Chamonix
City
Sallanches
ZIP/Postal Code
74700
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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