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
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Terminated
  • Study Participants

    26
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.
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 Started
Jan 31
2012
Primary Completion
Dec 31
2013
Study Completion
Dec 31
2013
Last Update
Nov 20
2019

Drug Mepivacaine

mepivacaine 1% 20 ml corresponding to 200 mg

  • Other names: experimental group

Drug Morphine

Morphine alone with a placebo nerve block

  • Other names: control group

Blind block with mepivacaine Experimental

Blind block with mepivacaine and intravenous morphine

Morphine Active Comparator

Intravenous Morphine and placebo blind block

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.
No Results Posted