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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01522534

Acronym

BPOP

Enrollment

Registered

2012-01-31

Start date

2012-01-31

Completion date

2013-12-31

Last updated

2019-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies, Injuries, Pain

Keywords

injuries, pain, Block, Nerve, morphine, Prehospital Emergency Care

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.

Interventions

DRUGMepivacaine

mepivacaine 1% 20 ml corresponding to 200 mg

DRUGMorphine

Morphine alone with a placebo nerve block

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Visual analog scale pain score	30 minutes

Secondary

Measure	Time frame
Total dose of morphine	60 minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026