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Analgesic Techniques for Robotic Prostatectomy Procedures

NCT07483840 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2026-03-19

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Analgesia

Interventions

PROCEDURE

Thoracic Erector Spinae Plane Block (ESPB-T)

This technique aims to provide both somatic and visceral analgesia through paravertebral spread of local anesthetic, potentially improving control of abdominal and pelvic pain while reducing opioid consumption and opioid-related side effects.

PROCEDURE

Rectus Sheath Block (RSB)

The RSB primarily targets anterior abdominal wall pain, particularly at laparoscopic port sites, and is intended to reduce postoperative parietal pain and opioid requirements while maintaining a favorable safety profile.

PROCEDURE

Low-dose Spinal Analgesia (SA)

This approach provides rapid and effective analgesia with a strong opioid-sparing effect and is commonly used to optimize early postoperative pain control, while carefully monitoring for opioid-related adverse effects.

Sponsors & Collaborators

  • Ente Ospedaliero Ospedali Galliera

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-06-01
Completion
2028-12-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07483840 on ClinicalTrials.gov