Surgery ScheduledPhase 2NCT01673542
Evaluating the Effectiveness of Dermal Analgesia Provided by the Application of Lidocaine and Prilocaine Cream 5% on the Puncture Site of Axillary Blocks
A Phase 2 study testing Lidocaine-Prilocaine 5% and DEXERYL in people with Surgery Scheduled, run by Poitiers University Hospital at 1 site in France.
Trial summary
Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the puncture site of axillary blocks.Our study includes 70 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery Scheduled
- What is being tested?
- Lidocaine-Prilocaine 5% and DEXERYL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2012to May 2013
- Phase
- Phase 2
- 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
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Hospitalized for upper extremity surgery scheduled
- Having an axillary block anesthesia.
- Free subject, without subordination or guardianship
- Patients undergoing a social security system or benefiting through a third party
- Informed consent and signed by the patient after clear and honest information on the study
Who cannot join
- Age < 18 years
- Hypersensitivity to lidocaine, prilocaine, to one of the excipients, castor oil and its derivatives
- Hypersensitivity to local anesthetics of the amide
- Congenital Methemoglobinemia
- Porphyrias
- Glucose-6-phosphate dehydrogenase
Show all 23Show fewer
- Hypersensitivity to any component of Dexeryl ®
- Disorders of atrioventricular conduction requiring permanent pacing not yet realized.
- Epilepsy uncontrolled by treatment
- Patients on anticoagulants
- Skin infection from the puncture site
- Patients with psychiatric disorders or dementia
- Cons-indication for infusion Isofundine ®:
- Severe congestive heart failure
- anuria
- oligoanuria
- Fluid retention
- hyperkalemia
- hypercalcemia
- Metabolic alkalosis
- Patients not receiving a social security system or not qualifying through a third party
- People receiving more protection ie minors, persons deprived of liberty by a judicial or administrative decision, guests staying in a hospital or office, adults under legal protection,
- Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transdermal, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, oophorectomy total )
Trial locations and contacts
1 site in 1 country.
About this study
Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required for a 50% difference with the standard deviation of the control group, a significance level of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35 patients per group.
The expected benefit is the reduction of pain at the skin puncture during the realization of BAX.
Improving professional practice and quality care
- Conditions
- Surgery Scheduled
- Being tested
- Lidocaine-Prilocaine 5%, DEXERYL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine-Prilocaine 5%Drug
DEXERYLDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine-Prilocaine 5% | Experimental | Not described Receives: Drug: Lidocaine-Prilocaine 5% |
| Dexeryl | Placebo comparator | Not described Receives: Drug: DEXERYL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the VAS groups of Lidocaine-Prilocaine 5% and Dexeryl ®
The main objective of the study is to compare the VAS (visual analogue scale) between groups of Lidocaine-Prilocaine 5% and Dexeryl ® in pain at the skin puncture for producing a block in patients undergoing axillary to an upper extremity surgery
Secondary outcomes (3)
evaluation pain
- Pain during injection of mepivacaine, measured by a visual analog scale (VAS) from 0 to 100 mm,
satisfaction
- Assessment of satisfaction of anesthetists
success
The success rate of the block defined by the absence of recourse to another anesthetic technique for inadequate analgesia (the use of hypnotic anxiolytic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery ScheduledStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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 2
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673542
- Sponsor's protocol ID
- EMLAX 2012-001976-13
- Status last verified
- Oct 2016
- First submitted
- 9 Jul 2012
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Dermal Analgesia Provided by the Application of Lidocaine and Prilocaine Cream 5% on the Puncture Site of Axillary Blocks
- ClinicalTrials.gov ID
- NCT01673542
- Acronym / sponsor ID
- EMLAX 2012-001976-13
- Conditions
- Surgery Scheduled
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- First posted
- 28 Aug 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.
Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required for a 50% difference with the standard deviation of the control group, a significance level of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35 patients per group.
The expected benefit is the reduction of pain at the skin puncture during the realization of BAX.
Improving professional practice and quality care
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine-Prilocaine 5% | Experimental | Drug: Lidocaine-Prilocaine 5% |
| Dexeryl | Placebo comparator | Drug: DEXERYL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Hospitalized for upper extremity surgery scheduled
- Having an axillary block anesthesia.
- Free subject, without subordination or guardianship
- Patients undergoing a social security system or benefiting through a third party
Key exclusion criteria (23 listed)
- Age < 18 years
- Hypersensitivity to lidocaine, prilocaine, to one of the excipients, castor oil and its derivatives
- Hypersensitivity to local anesthetics of the amide
- Congenital Methemoglobinemia
- Porphyrias
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 |
|---|---|---|
| Lidocaine-Prilocaine 5% | Drug | Lidocaine-Prilocaine 5% |
| DEXERYL | Drug | Dexeryl |
Primary outcome
Compare the VAS groups of Lidocaine-Prilocaine 5% and Dexeryl ®
The main objective of the study is to compare the VAS (visual analogue scale) between groups of Lidocaine-Prilocaine 5% and Dexeryl ® in pain at the skin puncture for producing a block in patients undergoing axillary to an upper extremity surgery
3 secondary outcomes
evaluation pain
satisfaction
success
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 12 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine-Prilocaine 5% and DEXERYL in people with Surgery Scheduled, run by Poitiers University Hospital 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 6 inclusion and 23 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 12 Oct 2016. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Compare the VAS groups of Lidocaine-Prilocaine 5% and Dexeryl ®. 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 12 Oct 2016.