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Search / Trial NCT06876155

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

Launched by SANA KLINIKUM OFFENBACH · Mar 13, 2025

Trial Information

Current as of April 29, 2025

Recruiting

Keywords

Prospective Randomised Trial 4 Quadrant Tap Block Transversus Abdominis Plane Block Ultrasound Guided Transversus Abdominis Plane Block Laparoscopic, Landmark Based Transversus Abdominis Plane Block

ClinConnect Summary

This clinical trial is studying two different ways to perform a procedure called a Transversus Abdominis Plane (TAP) Block, which helps manage pain after certain types of abdominal surgeries. One method uses ultrasound guidance by an anesthesiologist, while the other relies on traditional surgical landmarks. The main goal is to find out if either method leads to less pain after surgery and if there's a difference in the amount of pain relief medication needed. Researchers also want to see if one method takes longer than the other to perform.

To participate in this study, adults aged 65 to 74 who are having planned laparoscopic surgeries, like gallbladder removal or colorectal surgery, can join as long as they agree to take part. However, some individuals won't be eligible, including those who are pregnant, have allergies to the numbing medicine used, or have certain medical conditions that could complicate the procedure. Participants can expect to contribute to important research that may improve pain management for future patients undergoing similar surgeries.

Gender

ALL

Eligibility criteria

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

About Sana Klinikum Offenbach

Sana Klinikum Offenbach is a leading healthcare institution dedicated to providing high-quality medical care and advancing clinical research. As a prominent sponsor of clinical trials, the hospital is committed to fostering innovation in treatment methodologies and enhancing patient outcomes through rigorous scientific investigation. With a multidisciplinary team of experienced healthcare professionals and state-of-the-art facilities, Sana Klinikum Offenbach prioritizes patient safety and ethical standards while contributing to the development of new therapies across various medical fields. The institution's collaborative approach integrates clinical expertise with research initiatives, making it a pivotal player in the advancement of medical science.

Locations

Offenbach, Hessen, Germany

Patients applied

0 patients applied

Trial Officials

Prof.Dr. H. Mutlak

Principal Investigator

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported