Tramadol / Magnesium in Ropivacaine Solution in UG-bilateral TAP Block and Analgesia in Robotic Radical Prostatectomy

NCT ID: NCT07289321

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-09
• Study Completion Date: 2028-12-10

Brief 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 regional anesthesia technique. Participants will be men 40 to 80 years old with prostate cancer who are about to have robot-assisted radical prostatectomy. Initially, all males will be anaesthetised and then they will be randomly divided into three groups to undergo bilateral transverse abdominal plane (TAP) block under aseptic conditions. This involves insertion of a needle into the plane between internal oblique and transverse abdominal muscles under ultrasound guidance in order to inject the local anesthetic solution to relieve pain, as the responsible nerves run through the muscles of the abdominal wall. Specifically, 30 patients will receive only local anesthetic (ropivacaine), 30 will receive ropivacaine plus tramadol, and 30 will receive ropivacaine plus magnesium. Both the researchers and the participants will be unaware of (blind trial) the composition of the solution they will receive (double-blind randomized controlled trial). There will be no other differences in the other medications they will receive until the end of the surgery. Information will be collected in terms of the consumption of analgesic drugs both perioperatively and postoperatively (the first 24 hours of hospitalization), while the intensity of postoperative pain will also be assessed on a simple scale from 1 to 10 (Numerical Rating Scale - NRS). In addition, researchers will contact participants after 3 and 6 months to request an overall assessment of pain. The study will be conducted at the Aretaieio University Hospital in Athens, under the supervision of Anesthesiology Professors and will help us better understand the role of analgesic drugs already used in robotic surgery, which in the long term will contribute to the further development of even more effective protocols for the treatment of acute and chronic surgical pain. In general, the study is expected to last 3 years, which is the time required for patient enrollment, assessment of postoperative pain at 3 and 6 months, collection and analysis of all data. There are no additional risks or costs beyond those normally associated with radical prostatectomies, as nerve blocks (including TAP block) have already been adopted as analgesic methods at Aretaieio Hospital.

Conditions

Perioperative Pain in Robotic Prostatectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Team A - ropivacaine solution for bilateral TAP block

30 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).

Group Type: OTHER

Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy.

Intervention Type: OTHER

90 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 30 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).

Team B - ropivacaine plus tramadol solution for bilateral TAP block

30 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.

Group Type: ACTIVE_COMPARATOR

Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy.

Intervention Type: OTHER

90 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 30 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).

Team C - ropivacaine plus magnesium solution for bilateral TAP block

30 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

Group Type: ACTIVE_COMPARATOR

Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy.

Intervention Type: OTHER

90 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 30 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).

Interventions

Ultrasound - guided bilateral transversus abdominis plane block (TAP) in patients undergoing robotic-assisted radical prostatectomy.

90 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 30 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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Aretaieion University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eftychios Stavroulakis

Anesthesiologist, MD, DESA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aikaterini Melemeni, Anaesthetist

Role: STUDY_DIRECTOR

Aretaieion University Hospital

Locations

Aretaieion University Hospital of Athens

Athens, Attica, Greece

Countries

Greece

Other Identifiers

715/28-11-2025

Identifier Type: -

Identifier Source: org_study_id