Analgesic Techniques for Robotic Prostatectomy Procedures

NCT07483840 | Not Yet Recruiting

• 1 other identifier: 78UCS2025
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity

  Postoperative pain will be assessed using the Numerical Rating Scale (NRS), from 0 to 10, where 0 is no pain and 10 is maximum pain. The outcome evaluates the effectiveness of the different loco-regional analgesic techniques in controlling postoperative pain following robot-assisted radical prostatectomy or robot-assisted simple prostatectomy.

  From postoperative day 0 (day of surgery) to postoperative day 3 (G0-G3), assessed three times daily.

Secondary Outcomes (6)

• number of Postoperative Rescue analgesics

  In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)

• incidence of Postoperative nausea and vomiting

  In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)

• recovery after surgery

  In-hospital assessment from postoperative day 0 to discharge

• In-hospital length of stay

  day of discharge (up to 30 days)

• Complications

  In-hospital assessment at discharge and Follow-up assessment at 30 days after surgery (telephone interview)

Study Arms (3)

Thoracic Erector Spinae Plane Block (ESPB-T)

ACTIVE COMPARATOR

Patients randomized to this arm receive a bilateral ultrasound-guided thoracic ESPB (T10-T11) in addition to standardized general anesthesia.

Procedure: Thoracic Erector Spinae Plane Block (ESPB-T)

Rectus Sheath Block (RSB)

ACTIVE COMPARATOR

Patients allocated to this group receive a bilateral ultrasound-guided Rectus Sheath Block combined with standardized general anesthesia.

Procedure: Rectus Sheath Block (RSB)

Low-dose Spinal Analgesia (SA)

ACTIVE COMPARATOR

Patients randomized to this arm receive low-dose intrathecal morphine as part of a spinal analgesic technique, in combination with standardized general anesthesia.

Procedure: Low-dose Spinal Analgesia (SA)

Interventions

Thoracic Erector Spinae Plane Block (ESPB-T) PROCEDURE

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.

Thoracic Erector Spinae Plane Block (ESPB-T)

Rectus Sheath Block (RSB) PROCEDURE

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.

Rectus Sheath Block (RSB)

Low-dose Spinal Analgesia (SA) PROCEDURE

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.

Low-dose Spinal Analgesia (SA)

Eligibility Criteria

• Gender Eligibility Details: Participation in this study is limited to individuals who have a prostate and are scheduled to undergo robot-assisted prostate surgery. Eligibility is therefore based on anatomical and clinical criteria related to the presence of the prostate, which is required for the condition under investigation.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ente Ospedaliero Ospedali Galliera: lead

Study Sites (1)

Galliera Hospital

Genova, Ge, 16128, Italy

Location

Central Study Contacts

Marco Micali, MD

CONTACT

00393479980718; marco.micali@galliera.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: This is a prospective, randomized, single-center study.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: March 19, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

IT (1)