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

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.

Overview

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.

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 s

Primary outcome measures

• Perioperative fentanyl intravenous administration to patients. [Time frame: According to Nociception level (NOL) algometry during general anesthesia for the robotically assisted radical prostatectomy.]
• 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.]

Secondary outcome measures (2)

• 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 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Other

Study locations

Greece · 1 center

• Aretaieion University Hospital of Athens — Athens

Identifiers

NCT: NCT07289321 · 715/28-11-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗