Prospective, Randomized Comparative Study Between an Anesthesiological, Ultrasound-guided, and a Laparoscopic, Landmark-based Application of a Transversus Abdominis Plane (TAP) Block Based on Postoperative Pain Perception, Postoperative Analgesic Requirement, and Procedure Duration
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The Transversus Abdominis Plane Block (TAP) has become one of the most established and frequently performed trunk wall blocks for perioperative analgesia in abdominal surgical procedures. The TAP-Block can be performed by both surgeons and anaesthetists. The goal of this prospective, randomized study is to compare an anesthesiological, ultrasound-guided Transversus Abdominis Plane (TAP) Block with a laparoscopic, landmark-based Transversus Abdominis Plane (TAP) Block The main questions it aims to answer are: Primary Hypothesis: There are no differences in postoperative pain perception and analgesic requirements between the anaesthesiological ultrasound-guided and the surgical laparoscopic landmark-based TAP block Secondary Hypothesis: There are no significant differences in the duration of the procedure between the anaesthesiological, ultrasound-guided and the surgical laparoscopic landmark-based TAP block.
Director of the Department of Anaesthesiology, Intensive Care Medicine, and Pain Therapy at the Sana Klinikum Offenbach
RECRUITING
Offenbach
Contact Information
Primary
Prof. Dr. H. Mutlak
haitham.mutlak@sana.de
0049-69-8405-3802
Backup
M. Crombach, MD
mark.crombach@sana.de
0049-69-8405-7442
Time Frame
Start Date:2024-07-25
Estimated Completion Date:2025-07
Participants
Target number of participants:64
Treatments
Active_comparator: Arm 1: anaesthesiologically performed, ultrasound-guided, dual (lateral & subcostal) TAP block
The anaesthesiologically performed, ultrasound-guided, 4 quadrant-TAP block ( a combination of a lateral with a subcostal TAP block bilaterally) is performed by an experienced anaesthetist after induction of anaesthesia and before the start of the surgery. A total of 4 punctures are performed. Injection of a total of 60 ml ropivacaine 0.2% into the target compartment (2x 20 ml laterally, 2x 10 ml subcostally)
Active_comparator: Arm 2: surgically performed, laparoscopic landmark-based TAP block
The surgically performed, laparoscopic landmark-based assisted TAP block is performed intraoperatively by the surgeon after the establishment of the pneumoperitoneum and the insertion of the camera. The puncture needle is inserted from the outside under continuous laparoscopic visualization. The spread of the local anaesthetic is continuously visually monitored and should cause a bulging of M. transversus abdominis inward, away from M. obliquus internus ('Doyle's Bulge').~Injection of a total of 6 x 10 ml = 60 ml ropivacaine 0.2% into the target compartment (at 3 defined puncture sides bilaterally: at the anterior axillary line at 2 different, fixed heights and at the midclavicular line subcostally)