Analgesic Techniques for Robotic Prostatectomy Procedures

Starting soon · Not applicable

Conditions studied: Postoperative Analgesia

In brief

Robot-assisted radical prostatectomy and robot-assisted simple prostatectomy are minimally invasive procedures associated with reduced postoperative pain compared to open surgery. However, effective postoperative analgesia remains crucial to optimize recovery, reduce opioid consumption, minimize postoperative nausea and vomiting (PONV), and support early mobilization within Enhanced Recovery After Surgery (ERAS) pathways. Several loco-regional analgesic techniques have been proposed as alternatives to epidural analgesia, including thoracic Erector Spinae Plane Block (ESPB), Rectus Sheath Block (RSB), and low-dose intrathecal (spinal) analgesia. These techniques differ in their mechanisms of action, invasiveness, and potential impact on somatic and visceral pain control. This prospective, randomized, single-center study aims to compare the analgesic efficacy and postoperative recovery profiles of three loco-regional analgesic strategies in patients undergoing robot-assisted radical prostatectomy or robot-assisted simple prostatectomy. A total of 147 patients will be randomized to receive thoracic ESPB, bilateral RSB or low-dose spinal analgesia, in combination with standardized general anesthesia according to institutional ERAS protocols. Primary outcome is postoperative pain assessed using the Numerical Rating Scale (NRS). Secondary outcomes include opioid and antiemetic rescue requirements, incidence of PONV, time to recovery of oral intake and mobilization, length of hospital stay, and short- and medium-term postoperative complications, with follow-up up to 30 days after surgery.

Key facts

Study ID

NCT07483840

Run by

Ente Ospedaliero Ospedali Galliera

People needed

147

Starts

2026-07-01

Expected to finish

2028-12-01

Last updated by the study team

2026-03-19

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients scheduled for elective robot-assisted radical prostatectomy or robot-assisted simple prostatectomy
• Presence of a clinical indication for robot-assisted prostate surgery
• American Society of Anesthesiologists (ASA) physical status ≥ II
• Ability to understand the study procedures and provide written informed consent
• Agreement to participate in the study and compliance with study procedures

You may not qualify if…

• Patients undergoing open (laparotomic) or emergency surgery
• Contraindications to central or loco-regional anesthesia techniques, including but not limited to:
• Coagulation disorders or ongoing anticoagulation incompatible with neuraxial or regional anesthesia
• Known allergy or hypersensitivity to local anesthetics or study drugs
• Severe spinal deformities
• Severe aortic stenosis
• Systemic sepsis or infection at the site of needle insertion
• Refusal or inability to provide informed consent

Where it is running

• Galliera Hospital — Genova, Ge, Italy

Full record on ClinicalTrials.gov

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