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

NCT ID: NCT06876155

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2025-07-31

Brief 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.

Detailed Description

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. A TAP block is a so-called trunk wall block where a targeted injection of high volumes of local anesthetics is made into a space between two muscle fascias, the so-called inter-fascial space. In this inter-fascial space, the cutaneous nerve branches of various anterior rami of the spinal nerves run and innervate somatosensory in the respective dermatome, skin, soft tissues, and bones, as well as the outer layers of the pleura and peritoneum. Specifically, in a TAP block, the nerve fibers of the spinal nerves from the spinal segments Th6 to L1 can be anaesthetized by applying local anaesthetics between the Musculus obliquus internus abdominis and the Musculus transversus abdominis. The block produces somatic analgesia of the skin, muscles, and bony structures. Visceral analgesia of the internal organs is not achieved. Therefore, the TAP block mainly has an indication within the framework of a multimodal pain concept to save central and peripheral analgesics.

In the literature, it is shown that especially laparoscopic procedures benefit from a TAP block in terms of reducing postoperative reported pain intensity and reducing postoperative opioid requirements. Compared to simple wound infiltration with a local anaesthetic or simple local anaesthesia of the trocar insertion sites in a laparoscopy, the TAP block has been shown to be a more effective method in multiple studies.

The so-called Transversus Abdominis Plane compartment can be reached using various approaches (posterior, lateral, subcostal) and puncture techniques (landmark-based, ultrasound-guided, and surgical). A lateral approach is used primarily for analgesia in lower abdominal surgery (e.g., inguinal hernia repair). A subcostal approach is used primarily for analgesia in upper abdominal/supraumbilical surgery (e.g., cholecystectomy). A dual TAP block or '4 quadrant block,' the combination of a lateral with subcostal TAP block, could achieve better abdominal distribution of the local anaesthetic and more complete analgesia for the lower (T10-T12) and upper (T6-T9) abdomen.

The goal of this monocentric, prospective, randomised study is to compare an anesthesiological, ultrasound-guided "Transversus Abdominis Plane (TAP) Block" with a laparoscopic, landmark-based "Transversus Abdominis Plane (TAP) Block" in two parallel study arms.

Anaesthesia Induction and maintenance in both groups are standardised and similar.

The main questions 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.

A sample size calculation was performed before study start. The hypotheses will be verified by suitable statistical analysis. The randomization process is performed preoperatively using a closed envelope ('Sealed Envelope') that assigns a patient to one of the two intervention groups.

Conditions

Regional Anaesthesia; Transversus Abdominis Plane Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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

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)

Group Type: ACTIVE_COMPARATOR

Arm2: The surgically performed, laparoscopic landmark-based assisted TAP block

Intervention Type: PROCEDURE

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)

Interventions

Arm 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)

Intervention Type: PROCEDURE

Arm2: 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)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sana Klinikum Offenbach

OTHER

Sponsor Role: lead

Responsible Party

Haitham Mutlak

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof.Dr. H. Mutlak

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Offenbach, Hesse, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Prof. Dr. H. Mutlak

Role: CONTACT

haitham.mutlak@sana.de

0049-69-8405-3802

M. Crombach, MD

Role: CONTACT

mark.crombach@sana.de

0049-69-8405-7442

Facility Contacts

Prof. Dr. H. Mutlak, Prof.Dr.

Role: primary

haitham.mutlak@sana.de

0049-69-8405-3802

Mark M. Crombach

Role: backup

mark.crombach@sana.de

0049-69-8405-7442

Other Identifiers

2023-3472-evBO

Identifier Type: -

Identifier Source: org_study_id