Comparing two methods of administering a Transversus Abdominis Plane Block for pain relief after surgery
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
This study is testing two different ways to give a pain relief shot after abdominal surgery to see which method works better for managing pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sana Klinikum Offenbach Academic / other |
| Locations | 1 site (Offenbach, Hessen) |
| Trial ID | NCT06876155 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two techniques for administering a Transversus Abdominis Plane (TAP) Block, which is used for pain management in abdominal surgeries. One method is an anesthesiological approach using ultrasound guidance, while the other is a laparoscopic technique based on anatomical landmarks. The study will evaluate postoperative pain perception, analgesic requirements, and the duration of the procedure to determine if there are significant differences between the two methods. By analyzing these factors, the study seeks to optimize pain management strategies for patients undergoing laparoscopic surgeries.
Who should consider this trial
Good fit: Ideal candidates for this study are adults undergoing elective laparoscopic-assisted colorectal surgery, laparoscopic cholecystectomy, or laparoscopic fundoplication.
Not a fit: Patients with chronic pain syndromes, psychiatric conditions, or those on chronic opioid therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance postoperative pain management, leading to reduced analgesic requirements and improved recovery experiences for patients.
How similar studies have performed: Previous studies have indicated that TAP blocks can significantly reduce postoperative pain and opioid use, suggesting that this comparative approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Offenbach, Hessen
- Director of the Department of Anaesthesiology, Intensive Care Medicine, and Pain Therapy at the Sana Klinikum Offenbach — Offenbach, Hessen, Germany (Recruiting)
Study contacts
- Principal investigator: Prof.Dr. H. Mutlak — Department of Anaesthesiology, Intensive Care Medicine, and Pain Therapy at the Sana Klinikum Offenbach
- Study coordinator: Prof. Dr. H. Mutlak
- Email: haitham.mutlak@sana.de
- Phone: 0049-69-8405-3802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.