CompletedNot Applicable

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

Germany64 participantsStarted 2025-03-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of the postoperative pain perception using the NRS pain scale

Timeframe: First 24 hours postoperatively

Assessment of the postoperative analgesic requirements/consumption within the first 24 hours after surgery

Timeframe: First 24 hours postoperatively

Trial details

NCT IDNCT06876155

SponsorSana Klinikum Offenbach

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-06

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