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

Phase 3

Terminated

• Conditions: Injuries; Pain; Emergencies
• Interventions: Drug: Mepivacaine; Drug: Morphine

• Registration Number: NCT01522534
• Lead Sponsor: Centre Hospitalier Annecy Genevois

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-01-31
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blind block with mepivacaine	Mepivacaine	Blind block with mepivacaine and intravenous morphine
Morphine	Morphine	Intravenous Morphine and placebo blind block

Primary Outcome Measures

Name	Time	Method
Visual analog scale pain score	30 minutes

Secondary Outcome Measures

Name	Time	Method
Total dose of morphine	60 minutes

Trial Locations

Locations (6)

Centre Hospitalier Sallanches Chamonix; 🇫🇷 Sallanches, France

Centre Hospitalier Universitaire de GRENOBLE; 🇫🇷 Grenoble, France

Centre Hospitalier d'Albertville moutiers; 🇫🇷 Albertville, France

Centre medical d'Avoriaz; 🇫🇷 Morzine, France

Centre Hospitalier de la Region d'Annecy; 🇫🇷 Annecy, France

Centre Hospitalier de Chambéry; 🇫🇷 Chambery, France