Postoperative AnalgesiaPROPAINNCT07483840
Analgesic Techniques for Robotic Prostatectomy Procedures
A study testing Thoracic Erector Spinae Plane Block (ESPB-T), Rectus Sheath Block (RSB) and Low-dose Spinal Analgesia (SA) in people with Postoperative Analgesia, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.
Trial summary
Robot-assisted radical prostatectomy and robot-assisted simple prostatectomy are minimally invasive procedures associated with reduced postoperative pain compared to open surgery. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Thoracic Erector Spinae Plane Block (ESPB-T), Rectus Sheath Block (RSB) and Low-dose Spinal Analgesia (SA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Galliera Hospital
Genova, Ge, 16128
Marco Micali, MD, 00393479980718, marco.micali@galliera.it
Claudia Brusasco, MD
About this study
Official title: Postoperative Pain Control in Robotic Prostate Surgery: A Single-Center, Prospective, Randomized Study Comparing Three Analgesic Techniques.
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.
Read more
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.
- Conditions
- Postoperative Analgesia
- Being tested
- Thoracic Erector Spinae Plane Block (ESPB-T), Rectus Sheath Block (RSB), Low-dose Spinal Analgesia (SA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Erector Spinae Plane Block (ESPB-T)Procedure or 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 or 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 or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Thoracic Erector Spinae Plane Block (ESPB-T) |
| Rectus Sheath Block (RSB) | Active comparator | Patients allocated to this group receive a bilateral ultrasound-guided Rectus Sheath Block combined with standardized general anesthesia. Receives: Procedure: Rectus Sheath Block (RSB) |
| 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. Receives: Procedure: Low-dose Spinal Analgesia (SA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From postoperative day 0 (day of surgery) to postoperative day 3 (G0-G3), assessed three times daily.
Secondary outcomes (6)
number of Postoperative Rescue analgesics
Number of rescue analgesics requested per day (n)
Measured: 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
Measured: 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.
Measured: In-hospital assessment from postoperative day 0 to discharge
In-hospital length of stay
Length of hospital stay (n. days)
Measured: 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)
Measured: 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)
Measured: In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, single-center study.
- Masking
- None (open label)
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Ospedali Galliera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Micali, Ente Ospedaliero Ospedali Galliera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483840
- Sponsor's protocol ID
- 78UCS2025
- Acronym
- PROPAIN
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The authors share the entire study protocol (English version) and the CRF (Italian version).
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Control in Robotic Prostate Surgery: A Single-Center, Prospective, Randomized Study Comparing Three Analgesic Techniques.
- ClinicalTrials.gov ID
- NCT07483840
- Acronym / sponsor ID
- PROPAIN / 78UCS2025
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Ente Ospedaliero Ospedali GallieraUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective, randomized, single-center study.
| Arm | Type | Receives |
|---|---|---|
| Thoracic Erector Spinae Plane Block (ESPB-T) | Active comparator | 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. |
| Rectus Sheath Block (RSB) | Active comparator | Procedure: Rectus Sheath Block (RSB)Patients allocated to this group receive a bilateral ultrasound-guided Rectus Sheath Block combined with standardized general anesthesia. |
| Low-dose Spinal Analgesia (SA) | Active comparator | Procedure: 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic 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. | Procedure or surgery | Thoracic Erector Spinae Plane Block (ESPB-T) |
| Rectus 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. | Procedure or surgery | Rectus Sheath Block (RSB) |
| Low-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. | Procedure or surgery | Low-dose Spinal Analgesia (SA) |
Primary outcome
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.
6 secondary outcomes
number of Postoperative Rescue analgesics
Time frame: In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)
incidence of Postoperative nausea and vomiting
Time frame: In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)
recovery after surgery
Time frame: In-hospital assessment from postoperative day 0 to discharge
In-hospital length of stay
Time frame: day of discharge (up to 30 days)
Complications
Time frame: In-hospital assessment at discharge and Follow-up assessment at 30 days after surgery (telephone interview)
Type of rescue analgesic given
Time frame: In-hospital assessment from postoperative day 0 to postoperative day 3 (G0-G3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes. The authors share the entire study protocol (English version) and the CRF (Italian version).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Erector Spinae Plane Block (ESPB-T), Rectus Sheath Block (RSB) and Low-dose Spinal Analgesia (SA) in people with Postoperative Analgesia, run by Ente Ospedaliero Ospedali Galliera at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Micali, MD (00393479980718, marco.micali@galliera.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: From postoperative day 0 (day of surgery) to postoperative day 3 (G0-G3), assessed three times daily.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.