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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Rectus Sheath Block (RSB) | Active Comparator | Patients allocated to this group receive a bilateral ultrasound-guided Rectus Sheath Block combined with standardized general anesthesia. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to central or loco-regional anesthesia techniques, including but not limited to:
Refusal or inability to provide informed consent
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Micali, MD | Contact | 00393479980718 | marco.micali@galliera.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galliera Hospital | Genova | Ge | 16128 | Italy |
The authors share the entire study protocol (English version) and the CRF (Italian version).
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This is a prospective, randomized, single-center study.
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| 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. |
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| 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. |
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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 |
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) |