Analgesic Techniques for Robotic Prostatectomy Procedures (PROPAIN)

Postoperative Pain Control in Robotic Prostate Surgery: A Single-Center, Prospective, Randomized Study Comparing Three Analgesic Techniques.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Analgesia
• Intervention / Treatment: Procedure: Thoracic Erector Spinae Plane Block (ESPB-T); Procedure: Rectus Sheath Block (RSB); Procedure: Low-dose Spinal Analgesia (SA)

• Study Type: Interventional
• Enrollment (Estimated): 147
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Micali, MD; Phone Number: 00393479980718; Email: marco.micali@galliera.it

Study Locations

• Italy
  • Ge
    • Genova, Ge, Italy, 16128
      • Galliera Hospital
      • Contact: Marco Micali, MD; Phone Number: 00393479980718; Email: marco.micali@galliera.it
      • Sub-Investigator: Claudia Brusasco, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoracic Erector Spinae Plane Block (ESPB-T); 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); 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.
Active Comparator: Rectus Sheath Block (RSB); Patients allocated to this group receive a bilateral ultrasound-guided Rectus Sheath Block combined with standardized general anesthesia.	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.
Active Comparator: Low-dose Spinal Analgesia (SA); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of Postoperative Rescue analgesics	Number of rescue analgesics requested per day (n)	In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)
incidence of Postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting (PONV), using a NRS scale from 0 to 10, where 0 is no nausea and 10 is vomiting > 3 times/die	In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)
recovery after surgery	Day to recovery of oral intake (n); Day to first mobilization (n) These outcomes aim to evaluate the overall impact of each analgesic strategy on recovery quality, safety, and adherence to ERAS principles.	In-hospital assessment from postoperative day 0 to discharge
In-hospital length of stay	Length of hospital stay (n. days)	day of discharge (up to 30 days)
Complications	Occurrence of short- and medium-term postoperative complications (Clavien-Dindo classification from Grade I to Grade V)	In-hospital assessment at discharge and Follow-up assessment at 30 days after surgery (telephone interview)
Type of rescue analgesic given	Type of rescue analgesic administered (NSAIs, acetaminophen, opioid)	In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Ospedali Galliera

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 78UCS2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The authors share the entire study protocol (English version) and the CRF (Italian version).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No