Subgluteal Sciatic BlockPhase 4NCT00567450
Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block
A Phase 4 study testing ropivacaine and ropivacaine plus mepivacaine in people with Subgluteal Sciatic Block, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
In loco regional anesthesia, much more than for general anesthesia, the choice of the product is largely left at the discretion of the practitioner. Two categories of local anesthetics are distinguished according to their pharmacodynamic characteristics: products with a short time of installation and a short duration… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subgluteal Sciatic Block
- What is being tested?
- ropivacaine and ropivacaine plus mepivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Sep 2008
- Phase
- Phase 4
- 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
- age > 18 years
- surgery of the foot under sciatic block
Who cannot join
- no indication of locoregional anesthesia
- polyneuropathy or any neurological disease
- know hypersensitivity to local anesthetics
- porphyria
- atrio-ventricular block
- not controlled epilepsia
Show all 9Show fewer
- hypovolemia
- pregnancy
- anticoagulant treatment
Trial locations and contacts
1 site in 1 country.
France1 site
CHU d'Amiens, Pole Anesthesie Réanimation, Place Victor Pauchet
Amiens, 80054
About this study
Official title: Ropivacaine 0.75% vs Ropivacaine 0.75% Plus Mepivacaine 1.5% for Subgluteal Sciatic Bloc: a Prospective Double Blind Randomized Controlled Study
In loco regional anesthesia, much more than for general anesthesia, the choice of the product is largely left at the discretion of the practitioner. Two categories of local anesthetics are distinguished according to their pharmacodynamic characteristics: products with a short time of installation and a short duration period, and products with a longer delay of installation of the sensitive and motor block, but with a long-term duration. Indeed, the combined use of two products pharmacodynamically different seems to be of a practical interest.
This study provides a comparison of the onset of action of 30 ml of ropivacaine 0.75% and 30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% for the subgluteal sciatic nerve block. This is a prospective randomized double-blind study where the main criterion of judgment is the time of installation of a sensitive block compatible with surgery in the sciatic territory nerve. Fifteen patients per group were calculated to detect a 50% decrease of the onset of action in the combination group with a power of 90% and alpha to 5%, according to a previous pilot study. The secondary endpoints are the intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, as well as its possible side effects.
- Conditions
- Subgluteal Sciatic Block
- Being tested
- ropivacaine, ropivacaine plus mepivacaine
- Keywords
- sciatic block, ropivacaine, mepivacaine, locoregional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
30ml of a mixture of ropivacaïne 0.75%
ropivacaine plus mepivacaineDrug
30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%
| Study group | Role | What they receive |
|---|---|---|
| B | Active comparator | 30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% Receives: Drug: ropivacaine plus mepivacaine |
| A | Experimental | 30 ml of ropivacaine 0.75% Receives: Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve
Measured: 4h
Secondary outcomes (1)
intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, and its side effects.
Measured: 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subgluteal Sciatic BlockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Investigators
- Campana Philippe, MD, Principal investigator, Anesthesiology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567450
- Sponsor's protocol ID
- 2007-002254-31
- Other IDs
- EudraCT: 2007-002254-31, AFFSAPS: A70388-33
- Status last verified
- Jan 2009
- First submitted
- 4 Dec 2007
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ropivacaine 0.75% vs Ropivacaine 0.75% Plus Mepivacaine 1.5% for Subgluteal Sciatic Bloc: a Prospective Double Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00567450
- Acronym / sponsor ID
- 2007-002254-31
- Conditions
- Subgluteal Sciatic Block
- Keywords
- sciatic block, ropivacaine, mepivacaine, locoregional anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 5 Dec 2007 (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.
In loco regional anesthesia, much more than for general anesthesia, the choice of the product is largely left at the discretion of the practitioner. Two categories of local anesthetics are distinguished according to their pharmacodynamic characteristics: products with a short time of installation and a short duration period, and products with a longer delay of installation of the sensitive and motor block, but with a long-term duration. Indeed, the combined use of two products pharmacodynamically different seems to be of a practical interest.
This study provides a comparison of the onset of action of 30 ml of ropivacaine 0.75% and 30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% for the subgluteal sciatic nerve block. This is a prospective randomized double-blind study where the main criterion of judgment is the time of installation of a sensitive block compatible with surgery in the sciatic territory nerve. Fifteen patients per group were calculated to detect a 50% decrease of the onset of action in the combination group with a power of 90% and alpha to 5%, according to a previous pilot study. The secondary endpoints are the intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, as well as its possible side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Active comparator | Drug: ropivacaine plus mepivacaine30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% |
| A | Experimental | Drug: ropivacaine30 ml of ropivacaine 0.75% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- surgery of the foot under sciatic block
Key exclusion criteria (9 listed)
- no indication of locoregional anesthesia
- polyneuropathy or any neurological disease
- know hypersensitivity to local anesthetics
- porphyria
- atrio-ventricular block
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 |
|---|---|---|
| ropivacaine30ml of a mixture of ropivacaïne 0.75% | Drug | A |
| ropivacaine plus mepivacaine30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% | Drug | B |
Primary outcome
Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve
Time frame: 4h
1 secondary outcome
intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, and its side effects.
Time frame: 48h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
Related trials for Subgluteal Sciatic Block
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Using the Adductor Magnus Plain Block as an Innovative Approach for Sciatic Nerve Block for Lower Limb Surgeries.
Adductor Magnus Plain Injection for Sciatic Nerve Block
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.
Campana Philippe, MD principal investigator
Anesthesiology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ropivacaine and ropivacaine plus mepivacaine in people with Subgluteal Sciatic Block, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 2 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: finished, as of the sponsor's last update on 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve (time frame: 4h). 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 28 Jan 2009.