Comparison of the efficacy of two analgesic techniques for pain control in prostate surgery by laparoscopic approach

Phase 1

• Conditions: Prostate cancer; MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004089-16-ES
• Lead Sponsor: Consorci Sanitari Integral

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-28
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1. Informed consent form signed and dated, and willingness and ability
to accomplish the protocol requirements
2. Histologically confirmed prostate adenocarcinoma
3. Candidate for radical surgery by laparoscopic approach
4. Age> 18 years
5. Feasibility of performing regular monitoring
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Patients who do not agree to participate in the study
2. History of allergy to local anesthetics and opioid
3. Patients in chronic opioid treatment
4. Age <18 years

Study & Design

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