Postoperative Analgesia
Conditions
Brief summary
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
PROCEDUREThoracic 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.
PROCEDURERectus 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.
PROCEDURELow-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.
Sponsors
Ente Ospedaliero Ospedali Galliera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, randomized, single-center study.
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | 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
| Measure | Time frame | Description |
|---|---|---|
| number of Postoperative Rescue analgesics | In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3) | Number of rescue analgesics requested per day (n) |
| incidence of Postoperative nausea and vomiting | 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 |
| recovery after surgery | 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. |
| In-hospital length of stay | day of discharge (up to 30 days) | Length of hospital stay (n. days) |
| Complications | 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) |
| Type of rescue analgesic given | In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3) | Type of rescue analgesic administered (NSAIs, acetaminophen, opioid) |
Countries
Italy
Contacts
CONTACTMarco Micali, MD
Outcome results
None listed