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NCT Number: NCT07483840

Analgesic Techniques for Robotic Prostatectomy Procedures

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.

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Key information

Conditions

Postoperative Analgesia

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Postoperative Pain Intensity

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

    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.

Secondary outcomes

  1. number of Postoperative Rescue analgesics

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

    Number of rescue analgesics requested per day (n)

  2. incidence of Postoperative nausea and vomiting

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

    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

  3. recovery after surgery

    Time frame: In-hospital assessment from postoperative day 0 to discharge

    • 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.

  4. In-hospital length of stay

    Time frame: day of discharge (up to 30 days)

    Length of hospital stay (n. days)

  5. Complications

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

    Occurrence of short- and medium-term postoperative complications (Clavien-Dindo classification from Grade I to Grade V)

  6. Type of rescue analgesic given

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

    Type of rescue analgesic administered (NSAIs, acetaminophen, opioid)

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Micali, MD

CONTACT

[email protected]

00393479980718

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Ospedali Galliera

Other

Registry information

Official study title

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

Acronym: PROPAIN

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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