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Analgesic Techniques for Robotic Prostatectomy Procedures

ConditionPostoperative Analgesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorEnte Ospedaliero Ospedali Galliera

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients undergoing open (laparotomic) or emergency surgery

Coagulation disorders or ongoing anticoagulation incompatible with neuraxial or regional anesthesia

Known allergy or hypersensitivity to local anesthetics or study drugs

Severe spinal deformities

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thoracic Erector Spinae Plane Block (ESPB-T)

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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.

Treatment groups

147 Participants
are divided into 3 treatment groups
Group A: Thoracic Erector Spinae Plane Block (ESPB-T)Active comparator 1 intervention
Group B: Rectus Sheath Block (RSB)Active comparator 1 intervention
Group C: Low-dose Spinal Analgesia (SA)Active comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

number of Postoperative Rescue analgesics

Number of rescue analgesics requested per day (n)

Time frame
In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)
2

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

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

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.

Time frame
In-hospital assessment from postoperative day 0 to discharge
4

In-hospital length of stay

Length of hospital stay (n. days)

Time frame
day of discharge (up to 30 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ente Ospedaliero Ospedali Galliera

Lead sponsor

Source ClinicalTrials.gov

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