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

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

Interventions

OTHER

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).

Sponsors & Collaborators

• Aretaieion University Hospital

  lead OTHER

Principal Investigators

• Aikaterini Melemeni, Anaesthetist · Aretaieion University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-09

Primary Completion

2028-12-10

Completion

2028-12-10

Countries

• Greece

Study Locations