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Not yet recruiting NCT07483840

Analgesic Techniques for Robotic Prostatectomy Procedures

No phase Interventional Postoperative Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thoracic Erector Spinae Plane Block (ESPB-T), Rectus Sheath Block (RSB), Low-dose Spinal Analgesia (SA).
Who it may be relevant to
Registry conditions: Postoperative Analgesia. Basic parameters: No limits · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • Postoperative Pain Intensity [Time frame: From postoperative day 0 (day of surgery) to postoperative day 3 (G0-G3), assessed three times daily.]
Secondary outcome measures (6)
  • number of Postoperative Rescue analgesics [Time frame: In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)]
  • incidence of Postoperative nausea and vomiting [Time frame: In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)]
  • recovery after surgery [Time frame: In-hospital assessment from postoperative day 0 to discharge]
  • In-hospital length of stay [Time frame: day of discharge (up to 30 days)]
  • Complications [Time frame: In-hospital assessment at discharge and Follow-up assessment at 30 days after surgery (telephone interview)]
  • Type of rescue analgesic given [Time frame: In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Galliera Hospital — Genova

Identifiers

NCT: NCT07483840 · 78UCS2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗