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

NCT01522534 | Terminated Phase 3 DMC

• 1 other identifier: chra-2009-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 6

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.

Conditions

Injuries; Pain; Emergencies

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Visual analog scale pain score

  30 minutes

Secondary Outcomes (1)

• Total dose of morphine

  60 minutes

Study Arms (2)

Blind block with mepivacaine

EXPERIMENTAL

Blind block with mepivacaine and intravenous morphine

Drug: Mepivacaine

Morphine

ACTIVE COMPARATOR

Intravenous Morphine and placebo blind block

Drug: Morphine

Interventions

Mepivacaine DRUG

mepivacaine 1% 20 ml corresponding to 200 mg

Also known as: experimental group

Blind block with mepivacaine

Morphine DRUG

Morphine alone with a placebo nerve block

Also known as: control group

Morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe pain (VAS \> or = 60mm); injuries of the leg, ankle or foot

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead

Study Sites (6)

Centre Hospitalier d'Albertville moutiers

Albertville, 73208, France

Location

Centre Hospitalier de la Region d'Annecy

Annecy, 74374, France

Location

Centre Hospitalier de Chambéry

Chambéry, 73000, France

Location

Centre Hospitalier Universitaire de GRENOBLE

Grenoble, 38000, France

Location

Centre medical d'Avoriaz

Morzine, 74110, France

Location

Centre Hospitalier Sallanches Chamonix

Sallanches, 74700, France

Location

MeSH Terms

Conditions

Wounds and Injuries; Pain; Emergencies; Bites and Stings

Interventions

Mepivacaine; Morphine; Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Francois Xavier AGERON, MD

  Centre Hospitalier Annecy Genevois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: January 31, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

FR (6)