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

NCT06876155 | Completed

• 1 other identifier: 2023-3472-evBO
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anaesthesia; Transversus Abdominis Plane Block

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

Outcome Measures

Primary Outcomes (2)

• Assessment of the postoperative pain perception using the NRS pain scale

  Standardized pain assessments postoperatively are conducted by the in-house anaesthesiological pain service using a standardized pain form (which consists of a NRS Scoring in rest and at motion at fixed times \[1 hour, 2 hours, 6 hours, 12 hours, 24 hours\]). The anaesthesiological pain service is blinded to the procedure performed.

  First 24 hours postoperatively

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

  An assessment of the cumulative analgesic consumption in the first 24 hrs. postoperatively is conducted by the in-house anaesthesiological pain service. Both total opioid consumption (in mg) and consumption of basic analgetics (e.g. paracetamol, metamizole, etc.)(in mg) are measured. The anaesthesiological pain service is blinded to the procedure performed.

  First 24 hours postoperatively

Secondary Outcomes (1)

• Duration of the TAP block procedure

  perioperatively

Other Outcomes (3)

• PONV-Incidence

  First 24 hours postoperatively

• Duration of the patient stay in the recovery room

  First 24 hours postoperatively

• Complications

  First 24 hours postoperatively

Study Arms (2)

Arm 1: anaesthesiologically performed, ultrasound-guided, dual (lateral & subcostal) TAP block

ACTIVE COMPARATOR

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)

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

Arm 2: surgically performed, laparoscopic landmark-based TAP block

ACTIVE COMPARATOR

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)

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

Interventions

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

Arm 2: surgically performed, laparoscopic landmark-based TAP block

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

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

Arm 1: anaesthesiologically performed, ultrasound-guided, dual (lateral & subcostal) TAP block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sana Klinikum Offenbach: lead

Study Sites (1)

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

Offenbach, Hesse, 63069, Germany

Location

Study Officials

• Prof.Dr. H. Mutlak

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 14, 2025
• Study Start: March 25, 2025
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)