Regional AnaesthesiaNCT06876155
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
A study testing Arm 1: The anaesthesiologically performed, ultrasound-guided, 4 quadrant-TAP block ( a combination of a lateral with a subcostal TAP block bilaterally) and Arm2: The surgically performed, laparoscopic landmark-based assisted TAP block in people with Regional Anaesthesia and Transversus Abdominis Plane Block, run by Sana Klinikum Offenbach at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Anaesthesia, Transversus Abdominis Plane Block
- What is being tested?
- Arm 1: The anaesthesiologically performed, ultrasound-guided, 4 quadrant-TAP block ( a combination of a lateral with a subcostal TAP block bilaterally) and Arm2: The surgically performed, laparoscopic landmark-based assisted TAP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 25 Mar 2025to 6 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent of the adult patient
- Elective laparoscopic-assisted colorectal surgery, elective laparoscopic cholecystectomy, or elective laparoscopic fundoplication
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Director of the Department of Anaesthesiology, Intensive Care Medicine, and Pain Therapy at the Sana Klinikum Offenbach
Offenbach, Hesse, 63069
About this study
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"
Read more
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.
Read the 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.
- Being tested
- Arm 1: The anaesthesiologically performed, ultrasound-guided, 4 quadrant-TAP block ( a combination of a lateral with a subcostal TAP block bilaterally), Arm2: The surgically performed, laparoscopic landmark-based assisted TAP 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: The anaesthesiologically performed, ultrasound-guided, 4 quadrant-TAP block ( a combination of a lateral with a subcostal TAP block bilaterally)Procedure or surgery
Injection of a total of 60 ml ropivacaine 0.2% into the target compartment (2x 20 ml laterally, 2x 10 ml subcostally)
Arm2: The surgically performed, laparoscopic landmark-based assisted TAP blockProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Arm2: The surgically performed, laparoscopic landmark-based assisted TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: First 24 hours postoperatively
Secondary outcomes (1)
Duration of the TAP block procedure
Duration of the TAP block procedure, defined as the time from the first needle introduction to the completed application of the total amount of the local anaesthetic (in minutes).
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start25 Mar 2025
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Klinikum Offenbach
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Mutlak, Sana Klinikum Offenbach
- Investigators
- Prof.Dr. H. Mutlak, Principal investigator, Department of Anaesthesiology, Intensive Care Medicine, and Pain Therapy at the Sana Klinikum Offenbach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876155
- Sponsor's protocol ID
- 2023-3472-evBO
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06876155
- Acronym / sponsor ID
- 2023-3472-evBO
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sana Klinikum OffenbachUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: anaesthesiologically performed, ultrasound-guided, dual (lateral & subcostal) TAP block | Active comparator | Procedure: Arm 1: The anaesthesiologically performed, ultrasound-guided, 4 quadrant-TAP block ( a combination of a lateral with a subcostal TAP block bilaterally)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) |
| Arm 2: surgically performed, laparoscopic landmark-based TAP block | Active comparator | Procedure: Arm2: The surgically performed, laparoscopic landmark-based assisted TAP blockThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consent of the adult patient
- Elective laparoscopic-assisted colorectal surgery, elective laparoscopic cholecystectomy, or elective laparoscopic fundoplication
Key exclusion criteria (14 listed)
- Lack of patient consent
- Pregnancy and breastfeeding
- Allergies to local anaesthetics used
- Infections at the puncture sites
- History of complex abdominal wall reconstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | Arm 1: anaesthesiologically performed, ultrasound-guided, dual (lateral & subcostal) TAP block |
| Arm2: The surgically performed, laparoscopic landmark-based assisted TAP blockInjection 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 or surgery | Arm 2: surgically performed, laparoscopic landmark-based TAP block |
Primary outcome
Assessment of the postoperative pain perception using the NRS pain scale
Time frame: First 24 hours postoperatively
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.
Assessment of the postoperative analgesic requirements/consumption within the first 24 hours after surgery
Time frame: First 24 hours postoperatively
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.
1 secondary outcome
Duration of the TAP block procedure
Time frame: perioperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof.Dr. H. Mutlak principal investigator
Department of Anaesthesiology, Intensive Care Medicine, and Pain Therapy at the Sana Klinikum Offenbach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1: The anaesthesiologically performed, ultrasound-guided, 4 quadrant-TAP block ( a combination of a lateral with a subcostal TAP block bilaterally) and Arm2: The surgically performed, laparoscopic landmark-based assisted TAP block in people with Regional Anaesthesia and Transversus Abdominis Plane Block, run by Sana Klinikum Offenbach at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the postoperative pain perception using the NRS pain scale (time frame: First 24 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.