RecruitingNot ApplicableNCT06876155

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


Sponsor

Sana Klinikum Offenbach

Enrollment

64 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Consent of the adult patient
  • Elective laparoscopic-assisted colorectal surgery, elective laparoscopic cholecystectomy, or elective laparoscopic fundoplication

Exclusion Criteria14

  • Lack of patient consent
  • Pregnancy and breastfeeding
  • Allergies to local anaesthetics used
  • Infections at the puncture sites
  • History of complex abdominal wall reconstruction
  • Chronic pain syndrome
  • Fibromyalgia
  • Chronic opioid use
  • Chronic alcohol abuse
  • Chronic drug abuse (THC, amphetamines, cocaine, etc.)
  • Psychiatric preconditions (depression, schizophrenia, etc.)
  • Patients with impaired consciousness, communication, or cognitive function
  • Diagnosed coagulopathies (e.g., platelet count \<80,000/µL, PTT/aPTT- prolongation \>1.5 upper normal value)
  • Therapeutic anticoagulation

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Interventions

PROCEDUREArm 1: The anaesthesiologically performed, ultrasound-guided, 4 quadrant-TAP block ( a combination of a lateral with a subcostal TAP block bilaterally)

Injection of a total of 60 ml ropivacaine 0.2% into the target compartment (2x 20 ml laterally, 2x 10 ml subcostally)

PROCEDUREArm2: The surgically performed, laparoscopic landmark-based assisted TAP block

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)


Locations(1)

Director of the Department of Anaesthesiology, Intensive Care Medicine, and Pain Therapy at the Sana Klinikum Offenbach

Offenbach, Hesse, Germany

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NCT06876155


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