Perioperative Pain in Robotic ProstatectomyNCT07289321
Tramadol / Magnesium in Ropivacaine Solution in UG-bilateral TAP Block and Analgesia in Robotic Radical Prostatectomy
A study testing Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy. in people with Perioperative Pain in Robotic Prostatectomy, run by Aretaieion University Hospital at 1 site in Greece.
Trial summary
Tramadol and magnesium have already been researched in recent decades for their different roles in pain control. This clinical study will compare and re-evaluate their effect on the duration and quality of analgesia provided by a regional anesthesia technique. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Perioperative Pain in Robotic Prostatectomy
- What is being tested?
- Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteGreece
- Study dates
- 9 Dec 2025to 10 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males
- age 40-80 years
- physical status I-III according to the American Society of Anesthesiologists (ASA physical status)
- undergoing robotic-assisted radical prostatectomy using Da Vinci Xi.
Who cannot join
- Patients allergic to ropivacaine, tramadol, magnesium, or other drugs used in the study
- with coagulation disorders due to disease or medication,
- inflammation at the site of the block,
- addiction to alcohol
- history of opioid tolerance
- patients unable to complete the pain assessment scale
- patients unable or unwilling to provide written consent to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Tramadol or Magnesium in Local Anesthetic Solution on Ultrasound-guided Bilateral TAP Block During Robotic Radical Prostatectomy on Acute Perioperative Pain and Chronic Postoperative Pain.
Tramadol and magnesium have already been researched in recent decades for their different roles in pain control. This clinical study will compare and re-evaluate their effect on the duration and quality of analgesia provided by a regional anesthesia technique. Participants will be men aged 40 to 80 years with prostate cancer who are scheduled for robot-assisted radical prostatectomy. Initially, all patients will receive general anesthesia and will then be randomly divided into three groups of 35 patients each to undergo bilateral transverse abdominal plane (TAP) block under aseptic conditions. This involves insertion of a needle into the plane between the internal oblique and transverse abdominal muscles under ultrasound guidance in order to inject the local anesthetic solution, as the responsible nerves run through the muscles of the abdominal wall. Specifically, 35 patients will receive only local anesthetic (ropivacaine), 35 will receive ropivacaine plus tramadol, and 35 will receive ropivacaine plus magnesium. Neither the researchers nor the participants will be aware of the composition of the solution administered (double-blind randomized controlled trial). The two co-primary endpoints are: (1) intraoperative fentanyl consumption, guided by the Nociception Level (NOL) index, and (2) postoperative pain intensity assessed by the Numeric Rating Scale (NRS, 0-10) at 8 time points within the first 24 hours (at 5, 15, 30, and 60 minutes in the Post-Anesthesia Care Unit and at 2, 4, 8, and 24 hours on the ward, both at rest and on coughing), analysed by global repeated measures ANOVA. Secondary endpoints include total rescue tramadol consumption and time to first rescue dose in the first 24 postoperative hours, sedation level assessed by the Ramsay Sedation Scale and peripheral oxygen saturation (SpO₂) as safety parameters, and the incidence of postoperative nausea and vomiting (PONV). In addition, researchers will contact participants at 1, 3, and 6 months postoperatively to assess chronic pain. The sample size was determined by a pre-planned interim analysis (n=30): the fentanyl endpoint requires n=35 per group (N=105 total) to achieve 80% power (Cohen's f=0.308, α=0.05). The study will be conducted at Aretaieio University Hospital in Athens under the supervision of Anesthesiology Professors. There are no additional risks or costs beyond those normally associated with radical prostatectomy, as TAP block has already been adopted as an analgesic method at Aretaieio Hospital.
- Being tested
- Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy.Other
105 patients will be enrolled and divided in three different groups receiving U/G bilateral TAP block under aseptic conditions after induction of anesthesia and before the beginning of the surgery. The three groups of 35 patients each will differ in terms of the composition of the solution administered to them, in order to investigate any effect of 100mg tramadol or 300mg magnesium on the duration and the quality of the field block provided by ropivacaine injection. Both the total volume of the solution and the total amount of ropivacaine administered to all patients will be practically the same. Epinephrine will also be added to the local anesthetic solution so that the concentration will be 1:200,000. First of all, all the patients will receive general anesthesia and they will not differ in any way in terms of the doses (mg/kg) of medication they will receive for induction of anesthesia (according to their weight).
| Study group | Role | What they receive |
|---|---|---|
| Team A - ropivacaine solution for bilateral TAP block | Other | 35 Patients named team A will be administered an ultrasound-guided bilateral TAP block under aseptic conditions. The injected solution will contain 57 ml ropivacaine 0,375% plus 3 ml normal saline 0.9% and the needle used will be 20G 100mm. Both the total volume of the solution and the total amount of ropivacaine administered to all patients will be practically the same. Epinephrine will also be added to the local anesthetic solution so that the concentration will be 1:200,000. First of all, all the patients will receive general anesthesia and they will not differ in any way in terms of the doses (mg/kg) of medication they will receive for induction of anesthesia (according to their weight). Receives: Other: Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy. |
| Team B - ropivacaine plus tramadol solution for bilateral TAP block | Active comparator | 35 patients will receive a bilateral TAP block before robotic prostatectomy. The solution administered will be consisting of 57ml ropivacaine 0,375% plus 3 ml of tramadol (total dose 100mg) plus epinephrine 1:200.000 All the other conditions will be exactly the same. Receives: Other: Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy. |
| Team C - ropivacaine plus magnesium solution for bilateral TAP block | Active comparator | 35 patients will receive TAP block and the injected solution will be consisting 57ml ropivacaine 0,375% plus 3ml containing 300mg magnesium plus epinephrine 1:200.000 Receives: Other: Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative fentanyl intravenous administration to patients.
Minimal dose 2 μg/kg.
Measured: According to Nociception level (NOL) algometry during general anesthesia for the robotically assisted radical prostatectomy.
Intensity of acute postoperative pain according to numeric rating scale (NRS) and patient's overall satisfaction at 24 hours after surgery.
Measured: The assessment of the intensity of acute postoperative pain will be performed in the post-anesthesia unit at 5, 15, 30, and 60 minutes and then in the ward at 2, 4, 8, and 24 hours after surgery.
Secondary outcomes (3)
Τotal consumption of intravenous tramadol.
Measured: During the postoperative hospitalization of patients in the clinic in the first 24 hours after the end of the operation and the time of the first administration of tramadol.
Assessment of sedation level using the Ramsay Sedation Scale (RSS) and peripheral oxygen saturation (SpO₂) as safety parameters.
Measured: The assessment of sedation level using the Ramsay Sedation Scale and SpO₂ measurement will be performed in the post-anesthesia care unit at 5, 15, 30, and 60 minutes and then in the ward at 2, 4, 8, and 24 hours after surgery.
Postoperative nausea and vomiting (PONV).
Measured: During the 24 hours postoperative hospitalisation of patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start9 Dec 2025
- Primary completion10 Dec 2028 (estimated)
- Study completion10 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Pain in Robotic ProstatectomyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eftychios Stavroulakis, Aretaieion University Hospital
- Investigators
- Aikaterini Melemeni, Anaesthetist, Study director, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289321
- Sponsor's protocol ID
- 715/28-11-2025
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tramadol or Magnesium in Local Anesthetic Solution on Ultrasound-guided Bilateral TAP Block During Robotic Radical Prostatectomy on Acute Perioperative Pain and Chronic Postoperative Pain.
- ClinicalTrials.gov ID
- NCT07289321
- Acronym / sponsor ID
- 715/28-11-2025
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 10 Dec 2028 (estimated)
- Study completion
- 10 Dec 2028 (estimated)
- First posted
- 17 Dec 2025 (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.
Tramadol and magnesium have already been researched in recent decades for their different roles in pain control. This clinical study will compare and re-evaluate their effect on the duration and quality of analgesia provided by a regional anesthesia technique. Participants will be men aged 40 to 80 years with prostate cancer who are scheduled for robot-assisted radical prostatectomy. Initially, all patients will receive general anesthesia and will then be randomly divided into three groups of 35 patients each to undergo bilateral transverse abdominal plane (TAP) block under aseptic conditions. This involves insertion of a needle into the plane between the internal oblique and transverse abdominal muscles under ultrasound guidance in order to inject the local anesthetic solution, as the responsible nerves run through the muscles of the abdominal wall. Specifically, 35 patients will receive only local anesthetic (ropivacaine), 35 will receive ropivacaine plus tramadol, and 35 will receive ropivacaine plus magnesium. Neither the researchers nor the participants will be aware of the composition of the solution administered (double-blind randomized controlled trial). The two co-primary endpoints are: (1) intraoperative fentanyl consumption, guided by the Nociception Level (NOL) index, and (2) postoperative pain intensity assessed by the Numeric Rating Scale (NRS, 0-10) at 8 time points within the first 24 hours (at 5, 15, 30, and 60 minutes in the Post-Anesthesia Care Unit and at 2, 4, 8, and 24 hours on the ward, both at rest and on coughing), analysed by global repeated measures ANOVA. Secondary endpoints include total rescue tramadol consumption and time to first rescue dose in the first 24 postoperative hours, sedation level assessed by the Ramsay Sedation Scale and peripheral oxygen saturation (SpO₂) as safety parameters, and the incidence of postoperative nausea and vomiting (PONV). In addition, researchers will contact participants at 1, 3, and 6 months postoperatively to assess chronic pain. The sample size was determined by a pre-planned interim analysis (n=30): the fentanyl endpoint requires n=35 per group (N=105 total) to achieve 80% power (Cohen's f=0.308, α=0.05). The study will be conducted at Aretaieio University Hospital in Athens under the supervision of Anesthesiology Professors. There are no additional risks or costs beyond those normally associated with radical prostatectomy, as TAP block has already been adopted as an analgesic method at Aretaieio Hospital.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Team A - ropivacaine solution for bilateral TAP block | Other | Other: Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy.35 Patients named team A will be administered an ultrasound-guided bilateral TAP block under aseptic conditions. The injected solution will contain 57 ml ropivacaine 0,375% plus 3 ml normal saline 0.9% and the needle used will be 20G 100mm. Both the total volume of the solution and the total amount of ropivacaine administered to all patients will be practically the same. Epinephrine will also be added to the local anesthetic solution so that the concentration will be 1:200,000. First of all, all the patients will receive general anesthesia and they will not differ in any way in terms of the doses (mg/kg) of medication they will receive for induction of anesthesia (according to their weight). |
| Team B - ropivacaine plus tramadol solution for bilateral TAP block | Active comparator | Other: Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy.35 patients will receive a bilateral TAP block before robotic prostatectomy. The solution administered will be consisting of 57ml ropivacaine 0,375% plus 3 ml of tramadol (total dose 100mg) plus epinephrine 1:200.000 All the other conditions will be exactly the same. |
| Team C - ropivacaine plus magnesium solution for bilateral TAP block | Active comparator | Other: Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy.35 patients will receive TAP block and the injected solution will be consisting 57ml ropivacaine 0,375% plus 3ml containing 300mg magnesium plus epinephrine 1:200.000 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- males
- age 40-80 years
- physical status I-III according to the American Society of Anesthesiologists (ASA physical status)
- undergoing robotic-assisted radical prostatectomy using Da Vinci Xi.
Key exclusion criteria (7 listed)
- Patients allergic to ropivacaine, tramadol, magnesium, or other drugs used in the study
- with coagulation disorders due to disease or medication,
- inflammation at the site of the block,
- addiction to alcohol
- history of opioid tolerance
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 |
|---|---|---|
| Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy.105 patients will be enrolled and divided in three different groups receiving U/G bilateral TAP block under aseptic conditions after induction of anesthesia and before the beginning of the surgery. The three groups of 35 patients each will differ in terms of the composition of the solution administered to them, in order to investigate any effect of 100mg tramadol or 300mg magnesium on the duration and the quality of the field block provided by ropivacaine injection. Both the total volume of the solution and the total amount of ropivacaine administered to all patients will be practically the same. Epinephrine will also be added to the local anesthetic solution so that the concentration will be 1:200,000. First of all, all the patients will receive general anesthesia and they will not differ in any way in terms of the doses (mg/kg) of medication they will receive for induction of anesthesia (according to their weight). | Other | Team A - ropivacaine solution for bilateral TAP block, Team B - ropivacaine plus tramadol solution for bilateral TAP block, Team C - ropivacaine plus magnesium solution for bilateral TAP block |
Primary outcome
Perioperative fentanyl intravenous administration to patients.
Time frame: According to Nociception level (NOL) algometry during general anesthesia for the robotically assisted radical prostatectomy.
Minimal dose 2 μg/kg.
Intensity of acute postoperative pain according to numeric rating scale (NRS) and patient's overall satisfaction at 24 hours after surgery.
Time frame: The assessment of the intensity of acute postoperative pain will be performed in the post-anesthesia unit at 5, 15, 30, and 60 minutes and then in the ward at 2, 4, 8, and 24 hours after surgery.
3 secondary outcomes
Τotal consumption of intravenous tramadol.
Time frame: During the postoperative hospitalization of patients in the clinic in the first 24 hours after the end of the operation and the time of the first administration of tramadol.
Assessment of sedation level using the Ramsay Sedation Scale (RSS) and peripheral oxygen saturation (SpO₂) as safety parameters.
Time frame: The assessment of sedation level using the Ramsay Sedation Scale and SpO₂ measurement will be performed in the post-anesthesia care unit at 5, 15, 30, and 60 minutes and then in the ward at 2, 4, 8, and 24 hours after surgery.
Postoperative nausea and vomiting (PONV).
Time frame: During the 24 hours postoperative hospitalisation of patients.
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 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Perioperative Pain in Robotic Prostatectomy
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Laparoscopic TAP Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain
Prostate Cancer
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.
Aikaterini Melemeni, Anaesthetist study director
Aretaieion University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy. in people with Perioperative Pain in Robotic Prostatectomy, run by Aretaieion University Hospital at 1 site in Greece.
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 4 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 9 Oct 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 Greece. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative fentanyl intravenous administration to patients. (time frame: According to Nociception level (NOL) algometry during general anesthesia for the robotically assisted radical prostatectomy.). The study lists 2 primary outcomes in all. 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 9 Oct 2026.