Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2012-05-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Although this kind of anesthesia is among the most effective and safe available, the infiltration of local anesthetic is accompanied by pain in the majority of patients. This can be particularly important in ambulatory phlebectomy procedures, where large areas need to be anesthetized.
Numerous methods have been proposed to alleviate the pain associated with LIA, such as reducing the rate of administration or warming the anesthetic solution.
Sodium bicarbonate added in small concentrations, can also be effective in reducing significantly the pain associated with LIA. A recent trial has confirmed the viability and effectiveness of a solution of lidocaine 1% diluted in sodium bicarbonate 1.4%, in varicose vein surgery.
The purpose of this study is to evaluate the effectiveness in alleviating the pain associated with LIA, of a solution of mepivacaine 2%+epinephrine diluted with sodium bicarbonate 1.4%, compared with an analogous solution diluted with normal saline.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Alkalinised anesthetic solution
Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4%
4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium bicarbonate 1.4%
Non alkalinised anesthetic solution
Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%
4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium chloride 0.9%
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4%
4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium bicarbonate 1.4%
Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%
4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium chloride 0.9%
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Sinoatrial node disease or any degree of atrio-ventricular block
* Acute diseases
* Chronic kidney or liver disease
* Treatment with drugs that alter pain sensitivity (e.g. analgesics)
* Treatment with monoamine oxidase inhibitors or tricyclic antidepressants
* Major psychiatric disorders according to DSM IV-TR diagnostic criteria
* Alcohol abuse actual or recent as described in DSM IV-TR
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Campus Bio-Medico University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Raffaele Antonelli Incalzi
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stefano Ricci, M.D.
Role: STUDY_CHAIR
University Campus Bio-Medico
Leo Moro, M.D.
Role: PRINCIPAL_INVESTIGATOR
University Campus Bio-Medico
Francesco Maria Serino, M.D.
Role: PRINCIPAL_INVESTIGATOR
University Campus Bio-Medico
Raffaele Antonelli Incalzi, M.D.
Role: STUDY_DIRECTOR
University Campus Bio-Medico
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Policlinico Universitario Campus Bio-Medico
Rome, RM, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Creton D, Rea B, Pittaluga P, Chastanet S, Allaert FA. Evaluation of the pain in varicose vein surgery under tumescent local anaesthesia using sodium bicarbonate as excipient without any intravenous sedation. Phlebology. 2012 Oct;27(7):368-73. doi: 10.1258/phleb.2011.011026. Epub 2011 Nov 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EASE
Identifier Type: -
Identifier Source: org_study_id