InjuriesPhase 3BPOPNCT01522534
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
A Phase 3 study testing Mepivacaine and Morphine in people with Injuries and Pain, run by Centre Hospitalier Annecy Genevois at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injuries, Pain, Emergencies
- What is being tested?
- Mepivacaine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe pain (VAS > or = 60mm); injuries of the leg, ankle or foot
Who cannot join
- 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
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- Systolic blood pressure less than 90 mmHg
- Respiratory rate less than 16 per minute
- Glasgow coma scale < 14.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Hospitalier d'Albertville moutiers
Albertville, 73208
Centre Hospitalier de la Region d'Annecy
Annecy, 74374
Centre Hospitalier de Chambéry
Chambéry, 73000
Centre Hospitalier Universitaire de GRENOBLE
Grenoble, 38000
Centre medical d'Avoriaz
Morzine, 74110
Centre Hospitalier Sallanches Chamonix
Sallanches, 74700
About this study
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.
Read the 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.
- Conditions
- Injuries, Pain, Emergencies
- Being tested
- Mepivacaine, Morphine
- Keywords
- injuries, pain, Block, Nerve, morphine, Prehospital Emergency Care
- Medical subject headings
- Wounds and Injuries, Pain, Emergencies, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepivacaineDrug
Also called experimental group
mepivacaine 1% 20 ml corresponding to 200 mg
MorphineDrug
Also called control group
Morphine alone with a placebo nerve block
| Study group | Role | What they receive |
|---|---|---|
| Blind block with mepivacaine | Experimental | Blind block with mepivacaine and intravenous morphine Receives: Drug: Mepivacaine |
| Morphine | Active comparator | Intravenous Morphine and placebo blind block Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale pain score
Measured: 30 minutes
Secondary outcomes (1)
Total dose of morphine
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: not enough inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Xavier AGERON, MD, Principal investigator, Centre Hospitalier Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522534
- Sponsor's protocol ID
- chra-2009-001
- Acronym
- BPOP
- Status last verified
- Nov 2019
- First submitted
- 27 Jan 2012
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01522534
- Acronym / sponsor ID
- BPOP / chra-2009-001
- Conditions
- Injuries, Pain, Emergencies
- Keywords
- injuries, pain, Block, Nerve, morphine, Prehospital Emergency Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough inclusions
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blind block with mepivacaine | Experimental | Drug: MepivacaineBlind block with mepivacaine and intravenous morphine |
| Morphine | Active comparator | Drug: MorphineIntravenous Morphine and placebo blind block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe pain (VAS > or = 60mm); injuries of the leg, ankle or foot
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MepivacaineAlso: experimental groupmepivacaine 1% 20 ml corresponding to 200 mg | Drug | Blind block with mepivacaine |
| MorphineAlso: control groupMorphine alone with a placebo nerve block | Drug | Morphine |
Primary outcome
Visual analog scale pain score
Time frame: 30 minutes
1 secondary outcome
Total dose of morphine
Time frame: 60 minutes
Results and safety
The study was stopped early (reason given: not enough inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Xavier AGERON, MD principal investigator
Centre Hospitalier Annecy Genevois
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mepivacaine and Morphine in people with Injuries and Pain, run by Centre Hospitalier Annecy Genevois at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: not enough inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale pain score (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019; AzTrials last refreshed its copy on 30 Oct 2026.