Postoperative Pain Control in Robotic Prostate Surgery: A Single-Center, Prospective, Randomized Study Comparing Three Analgesic Techniques.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 147
- Locations
- 1
- Primary Endpoint
- Postoperative Pain Intensity
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts 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
Arms & Interventions
Low-dose Spinal Analgesia (SA)
Patients randomized to this arm receive low-dose intrathecal morphine as part of a spinal analgesic technique, in combination with standardized general anesthesia.
Intervention: Low-dose Spinal Analgesia (SA) (Procedure)
Thoracic Erector Spinae Plane Block (ESPB-T)
Patients randomized to this arm receive a bilateral ultrasound-guided thoracic ESPB (T10-T11) in addition to standardized general anesthesia.
Intervention: Thoracic Erector Spinae Plane Block (ESPB-T) (Procedure)
Rectus Sheath Block (RSB)
Patients allocated to this group receive a bilateral ultrasound-guided Rectus Sheath Block combined with standardized general anesthesia.
Intervention: Rectus Sheath Block (RSB) (Procedure)
Outcomes
Primary Outcomes
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
- number of Postoperative Rescue analgesics(In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3))
- incidence of Postoperative nausea and vomiting(In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3))
- recovery after surgery(In-hospital assessment from postoperative day 0 to discharge)
- In-hospital length of stay(day of discharge (up to 30 days))
- Complications(In-hospital assessment at discharge and Follow-up assessment at 30 days after surgery (telephone interview))
- Type of rescue analgesic given(In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3))
Investigators
Marco Micali
Principal investigator
Ente Ospedaliero Ospedali Galliera