An interventional study of Thoracic Erector Spinae Plane Block (ESPB-T) and Rectus Sheath Block (RSB) in Postoperative Analgesia, sponsored by Ente Ospedaliero Ospedali Galliera. Not yet recruiting at 1 site in Italy. Open to male participants. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Ente Ospedaliero Ospedali Galliera · Not applicable, Interventional, and Treatment
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.
Ente Ospedaliero Ospedali Galliera is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
to central or loco-regional anesthesia techniques, including but not limited to:
Refusal or inability to provide
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to this arm receive a bilateral ultrasound-guided thoracic ESPB (T10-T11) in addition to standardized general anesthesia.
Procedure: Thoracic Erector Spinae Plane Block (ESPB-T)
Patients allocated to this group receive a bilateral ultrasound-guided Rectus Sheath Block combined with standardized general anesthesia.
Procedure: Rectus Sheath Block (RSB)
Patients randomized to this arm receive low-dose intrathecal morphine as part of a spinal analgesic technique, in combination with standardized general anesthesia.
Procedure: Low-dose Spinal Analgesia (SA)
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.
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.
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.
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.
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)
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)
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
In-hospital length of stay
Length of hospital stay (n. days)
Time frame: 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)
Time frame: 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)
Time frame: In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)
Plan to share: Yes — The authors share the entire study protocol (English version) and the CRF (Italian version).
Supporting information: Study protocol, Clinical study report
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jun 2028, 23 months later.
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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