- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01522534
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 (BPOP)
November 18, 2019 updated by: Centre Hospitalier Annecy Genevois
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Albertville, France, 73208
- Centre Hospitalier d'Albertville moutiers
-
Annecy, France, 74374
- Centre Hospitalier de la Région d'Annecy
-
Chambery, France, 73000
- Centre Hospitalier de Chambéry
-
Grenoble, France, 38000
- Centre Hospitalier Universitaire de Grenoble
-
Morzine, France, 74110
- Centre medical d'Avoriaz
-
Sallanches, France, 74700
- Centre Hospitalier Sallanches Chamonix
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Blind block with mepivacaine
Blind block with mepivacaine and intravenous morphine
|
mepivacaine 1% 20 ml corresponding to 200 mg
Other Names:
|
Active Comparator: Morphine
Intravenous Morphine and placebo blind block
|
Morphine alone with a placebo nerve block
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual analog scale pain score
Time Frame: 30 minutes
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total dose of morphine
Time Frame: 60 minutes
|
60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Francois Xavier AGERON, MD, Centre Hospitalier Annecy Genevois
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 27, 2012
First Submitted That Met QC Criteria
January 30, 2012
First Posted (Estimate)
January 31, 2012
Study Record Updates
Last Update Posted (Actual)
November 20, 2019
Last Update Submitted That Met QC Criteria
November 18, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- chra-2009-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Mepivacaine
-
Universitat Internacional de CatalunyaCompleted
-
Cairo UniversityNot yet recruitingSymptomatic Irreversible Pulpitis
-
Hospital for Special Surgery, New YorkCompletedArthroscopic Knee SurgeryUnited States
-
University Health Network, TorontoCompleted
-
Region SkaneNot yet recruitingCarpal Tunnel Syndrome
-
University of Campinas, BrazilFundação de Amparo à Pesquisa do Estado de São PauloCompletedLocal Anesthetic EffectivenessBrazil
-
University Hospital, AntwerpCompletedSurgery | Anesthesia | Brachial Plexus Block | Nerve BlockBelgium
-
Brigham and Women's HospitalMassachusetts Institute of TechnologyCompletedHealthy | Compartment Syndrome of LegUnited States
-
Centre Hospitalier Universitaire, AmiensCompleted
-
Medical University of South CarolinaRecruiting