Bladder cancer
Conditions
Interventions
Trade Name: LIDOCAÍNA 2% INYECTABLE BRAUN MINIPLASCO
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Lidocaine
CAS Number: 137-58-6
Current Sponsor code: LIDOCAINA
Other descriptive n
Sponsors
Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients of both genre aged between 18 and 85 years, BMI less than 40. 2. Bladder tumor diagnosed by ultrasound and / or flexible cystoscopy candidate for surgery transurethral resection of bladder tumor side face within three months of diagnosis. 3. Single or multi-level lesion located anterior quadrant of the side faces bladder. 4. Clinical indication for transurethral resection (TUR) of bladder tumor. 5. Patients who signed informed consent indicating that they have been informed of all pertinent aspects of the trial. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 52
Exclusion criteria
Exclusion criteria: 1. Physical State assessed by ASA> 4 and / or ECOG> 4 2. Allergy or hypersensitivity to lidocaine or any of the excipients of the study drug. 3. Pregnant or breast-feeding. 4. Participation in a clinical drug research before 3 months in pre-drug administration. 5. Concomitant use of the following drugs: amiodarone, disopyramide, phenobarbital, phenytoin, monoaminooxidas inhibitors. 6. Subjects with contraindications for regional anesthesia: patient refusal, skin infection, severe neurology pathology, severe thrombocytopenia (platelet count <100,000) receiving both treatment groups.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess whether the blockade of the obturator nerve at the groin ultrasound-guided lidocaine 2%, reduces adductor muscle spasm risk compared to placebo use during transurethral resection of bladder tumor located in a side face (inferolateral portion).;Secondary Objective: Analyze possible differences in: a) Risk of bladder perforations, b) Quality of resection, based on the correct representation of muscular layer and c) Time of resection between the two groups;Primary end point(s): Presence (or absence) of adductor muscle contraction during transurethral resection.;Timepoint(s) of evaluation of this end point: During transurethral resection (it will finish in a maximum of 2 hours) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Presence of uncontrolled bladder perforation at the end resection. -Quality Resection determined by the correct representation of muscle layer at the discretion of the study pathologist (presence or absence of the muscular layer) -Time Resection.;Timepoint(s) of evaluation of this end point: Maximum of 6 hours | — |
Countries
Spain
Contacts
Public ContactServicio de Urología y Traspl. Rena
Servicio de Urología y Trasplante Renal
Outcome results
None listed