BPOP: 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

Sponsor

Centre Hospitalier Annecy Genevois (Other)

Overall Status

Terminated

CT.gov ID

NCT01522534

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

4.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Injuries Pain Emergencies	Drug: Mepivacaine Drug: Morphine	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Visual analog scale pain score [30 minutes]

Secondary Outcome Measures

Total dose of morphine [60 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Hospitalier d'Albertville moutiers	Albertville	France	73208
2	Centre Hospitalier de la Region d'Annecy	Annecy	France	74374
3	Centre Hospitalier de Chambéry	Chambery	France	73000
4	Centre Hospitalier Universitaire de GRENOBLE	Grenoble	France	38000
5	Centre medical d'Avoriaz	Morzine	France	74110
6	Centre Hospitalier Sallanches Chamonix	Sallanches	France	74700