Analgesic Techniques for Robotic Prostatectomy Procedures

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorEnte Ospedaliero Ospedali Galliera

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients undergoing open (laparotomic) or emergency surgery

Coagulation disorders or ongoing anticoagulation incompatible with neuraxial or regional anesthesia

Known allergy or hypersensitivity to local anesthetics or study drugs

Severe spinal deformities

Trial design

Treatments tested in this trial

  • Thoracic Erector Spinae Plane Block (ESPB-T)
  • Rectus Sheath Block (RSB)
  • Low-dose Spinal Analgesia (SA)

Treatment groups

147 Participants
are divided into 3 treatment groups