Ensayo clínico aleatorizado abierto para analizar la tolerancia individual al dolor en el empleo de dos técnicas anestésicas para la realización de la biopsia de próstata de saturación

Abstract

lntroduction:Prostate cancer (PC) is the third most frequent tumor location in Spanish men. A prostate biopsy is the fundamental diagnostic method to obtain prognostic information and decide the most appropriate treatment. Despite being a minimally invasive procedure, it can produce sorne discomfort and pain, causing many patients to avoid future biopsies. No studies are evaluating local anesthesia in patients who undergo saturation prostate biopsies. Material and method: Alter approval by the ethics committee and the Spanish drug agency, a prospective and randomized study was carried out with 100 patients with at least two previous negative biopsies and candidates far saturation prostate biopsy. lt was randomized in -a 1: 1 ratio into the control group (intravenous sedation with midazolam, fentanyl, and ketamine) and the intervention group (1% periprostatic mepivacaine). Twenty-four cylinders were collected from ali patients. The mean DE was: age (66.2±5.9), BMI (27.84±4.2), total PSA (8.31±5.0), % free PSA (19.06±6, 3), and prostate vol u me (72.54±33.2). The primary variable is the visual analog scale (VAS). Results: Both groups are homogeneous in the main clinical variables (age, PSA, prostate volume, and BMI). The technique was effective in ali patients in the intervention group. The mean global pain was mild (0.825±1.36). Significan! differences were observed between both groups at the time of the biopsy (0.548±1.48 vs. 1.102±1.18, p <0.001), being more effective in the sedation group. However, there were not statistical differences at the time of hospital discharge (0.509±1.15 vs. 0.369±0, 9; p = 0.541). The complication rate was very low, less than 10%, with hemorrhagic events being the most frequent, but without clinical repercussions. Conclusions: The periprostatic infiltration technique of Mepivacaine 1% is effective and safe in controlling pain perceived in saturation prostate biopsy. This technique makes it possible to reduce preoperative studies and anesthetic consultations associated with intravenous sedation. Together, it will allow better management of financia! and healthcare resources and the availability of the operating room.