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

Pain Clinical Trial

— BPOP  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01522534
• Other study ID #: chra-2009-001
• Status: Terminated
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2019
• Source: Centre Hospitalier Annecy Genevois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Injuries
• Pain

Intervention

Drug:
• Mepivacaine
mepivacaine 1% 20 ml corresponding to 200 mg
• Morphine
Morphine alone with a placebo nerve block

Locations

Country	Name	City	State
France	Centre Hospitalier d'Albertville moutiers	Albertville
France	Centre Hospitalier de la Region d'Annecy	Annecy
France	Centre Hospitalier de Chambéry	Chambery
France	Centre Hospitalier Universitaire de GRENOBLE	Grenoble
France	Centre medical d'Avoriaz	Morzine
France	Centre Hospitalier Sallanches Chamonix	Sallanches

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Annecy Genevois

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale pain score		30 minutes
Secondary	Total dose of morphine		60 minutes