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

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.

NCT Number	NCT07289321
Lead Sponsor	Aretaieion University Hospital
Conditions	Perioperative Pain in Robotic Prostatectomy
Enrollment	90 participants
Start Date	2025-12-09
Primary Completion	2028-12-10 (estimated)
Study Completion	2028-12-10 (estimated)
Updated on ClinicalTrials.gov	2025-12-23