Analgesic effectiveness of ultrasound-guided bilateral Transversus Abdominis Plane (TAP) block technique for laparoscopic radical prostatectomy surgery

Analgesic effectiveness of ultrasound-guided bilateral Transversus Abdominis Plane (TAP) block technique for laparoscopic radical prostatectomy: a prospective, randomized, simple-blind study - Analgesic effectiveness of ultrasound-guided bilateral TAP block technique for PRL

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005246-31-ES

Enrollment

Unknown

Registered

2017-02-10

Start date

2017-03-20

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients scheduled for elective laparoscopic radical prostatectomy surgery

Interventions

Trade Name: Levobupivacaina Product Name: Levobupivacaine Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: levobupivacaine Other descriptive name: levobupivacaine Concentratio

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - ASA physical status I-III - Male - Aged 18-90 years - Scheduled for elective laparoscopic radical prostatectomy - Able to provide written informed consent 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 56 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56

Exclusion criteria

Exclusion criteria: - Unable to provide written informed consent - Unable to understand the Visual Analog Scale (VAS) for pain - Allergy to local anesthetic agents or other drug of the study - Preoperative chronic dependence upon opioid medication - Contraindication for TAP block: Coagulopathy, use of anticoagulant drugs or infection of the point of injection

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the effectiveness of the US-guided bilateral TAP block tecnique as part of a multimodal analgesic plan that reduces the postoperative pain in the laparoscopic radical prostatectomy surgery compared with the IV conventional analgesia;Secondary Objective: Not applicable;Primary end point(s): - Decrease the intensity of postoperative pain after laparoscopic radical prostatectomy surgery, measured with the VAS scale;Timepoint(s) of evaluation of this end point: First 48 hours of postoperative period	—

Measure

Time frame

Main Objective: Evaluate the effectiveness of the US-guided bilateral TAP block tecnique as part of a multimodal analgesic plan that reduces the postoperative pain in the laparoscopic radical prostatectomy surgery compared with the IV conventional analgesia;Secondary Objective: Not applicable;Primary end point(s): - Decrease the intensity of postoperative pain after laparoscopic radical prostatectomy surgery, measured with the VAS scale;Timepoint(s) of evaluation of this end point: First 48 hours of postoperative period

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: First 48 hours of postoperative period;Secondary end point(s): - Increase the time to first request for rescue analgesia in the postoperative period - Decrease postoperative nausea and vomiting - Decrease postoperative opioid consumption	—

Countries

Spain

Contacts

Public ContactServicio de Anestesia

Complexo Hospitalario Universitario de Pontevedra

+34986800511

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026