Obturator nerve anesthesia guided by ultrasound to facilitate complete resection of bladder tumor

• Conditions: Bladder cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004725-40-ES
• Lead Sponsor: Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-11
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>a) Risk of bladder perforations,<br>b) Quality of resection, based on the correct representation of muscular layer and<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Presence of uncontrolled bladder perforation at the end resection.<br>-Quality Resection determined by the correct representation of muscle layer at the discretion of the study pathologist (presence or absence of the muscular layer)<br>-Time Resection.;Timepoint(s) of evaluation of this end point: Maximum of 6 hours