There is no consensus about the most appropriate local anesthetic, and 1% mepicavain and 2% lidocaine uses can be postulated indistinctly. This project was born with the intention of highlighting the level of anesthesia achieved, the side effects and the safety profile of the use of 1% mepivacaine, 2% lidocaine or 1% lidocaine solution + 8.4% sodium bicarbonate (ratio 10 :1 ml) to achieve local anesthesia in basic pleural intervention.
Conditions
Interventions
Product Name: mepivacaine 2%
Pharmaceutical Form: Solution for injection/infusion
Product Name: 1% lidocaine hydrochloride
Pharmaceutical Form: Solution for injection/infusion
Product Name: 1% lidoc
Sponsors
None
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Informed consent signature b. > 18 years old c. Performance of basic pleural interventional procedures (diagnostic / therapeutic thoracocentesis and placement of endothoracic drainage) d. Hemodynamic stability and prior therapeutic indication of the need for basic pleural techniques. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: a. lack of informed consent b. severe hemodynamic disturbance c. Known allergy to any of the anesthetic drugs used: hypersensitivity to lidocaine and/or amide-type local anesthetics Presence of any of the following conditions: Cardiogenic shock, Severe cardiac conduction dysfunction, Decompensated heart failure, Degenerative nerve disease, under 18 years old F. refusal to participate by the patient g. procedures performed for life-threatening reasons h. Need for advanced pleural interventional procedures (pleural biopsy, tunneled pleural drainage, thoracoscopy, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyze the efficacy of local anesthesia achieved prior to performing diagnostic and therapeutic pleural techniques, comparing the use of 1% lidocaine (undiluted), 2% mepivacaine (undiluted) and 1% lidocaine solution + sodium bicarbonate 8 .4% (ratio 10:1 ml), as well as secondary effects directly derived from the administration of said drugs and the total dose administered to achieve correct anesthesia.;Secondary Objective: a. To know the drug with the highest safety profile for use in pleural techniques. b. To know the minimum dose necessary for adequate anesthesia prior to performing pleural techniques. c. Degree of patient satisfaction in relation to the analgesia achieved after carrying out the diagnostic or therapeutic technique.;Primary end point(s): • • Anthropometric data (sex, age, weight and height) • • Type of procedure performed (diagnostic/ therapeutic thoracocentesis) • • Type of gauge used (Fr) • • Volume of pleural liquid extracted (expressed in ml) • • Biochemical characteristics of the extracted pleural fluid • • Vital signs before and after the procedure (systolic blood pressure, diastolic blood pressure, heart rate and saturation measured by pulse oximetry) • • amount of anesthetic drug used for proper anesthesia (expressed in ml) • • Immediate complications.;Timepoint(s) of evaluation of this end point: • • Anthropometric data (sex, age, weight and height) • • Type of procedure performed (diagnostic/ therapeutic thoracocentesis) • • Type of gauge used (Fr) • • Volume of pleural liquid extracted (expressed in ml) • • Biochemical characteristics of the extracted pleural fluid • • Vital signs before and after the procedure (systolic blood pressure, diastolic blood pressure, heart rate and saturation measured by pulse oximetry) • • amount of anesthetic drug used for proper anesthesia (expressed in ml) • • Immediate complications. Data will be colleted during three consecutive months, and after this the data analyse will be carry | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • • Anatomical location of the pleural effusion • • amount (ultrasound measurement expressed in mm of the distance between the parietal pleura and the visceral pleura immediately prior to the procedure);Timepoint(s) of evaluation of this end point: • • Immediate complications. Data will be colleted during three consecutive months, and after this the data analyse will be carry on | — |
Countries
Spain
Contacts
Public ContactBlanca De Vega
Hospital Clinico Universitario Valladolid
Outcome results
None listed