Postoperative AnalgesiaMTAPA and ESPNCT06660966
Comparison Of M-TAPA Block and ESP Block İn Laparoscopic Cholecystectomy
A study testing M TAPA block and ESP block group in people with Postoperative Analgesia, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
After cholecystectomy, modified-thoracoabdominal nerve block (M-TAPA) is a newly applied technique in upper abdominal surgery for postoperative analgesia. In recent years, block methods such as erector spina plane (ESP), paravertebral (PVB), transverses abdominis plane (TAP) have also been applied in these surgeries. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- M TAPA block and ESP block group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2023to 16 Jan 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III ,
- 18-70 yaş,
- Elective surgery
Who cannot join
- Pregnancy,
- Patient with emegency,
- Patients allergic to local anesthetics,
- Patient with coagulopaty,
- Uncooperative, mentally retarded patients
- Infection on the injection site
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Gaziantep
Şehitkamil, Gaziantep, 27031
About this study
Official title: Comparison of the Effectiveness of M TAPA Block and ESP Block in Laparoscopic Cholecystectomy
After cholecystectomy, modified-thoracoabdominal nerve block (M-TAPA) is a newly applied technique in upper abdominal surgery for postoperative analgesia. In recent years, block methods such as erector spina plane (ESP), paravertebral (PVB), transverses abdominis plane (TAP) have also been applied in these surgeries. MTAPA has been defined as a technique that is performed in the supine position and is easier to apply than the other mentioned blocks. In our study, we aimed to investigate the effectiveness of this block.
Read the detailed description
After laparoscopic cholecystectomy, most patients experience moderate to severe pain, especially in the first 24 hours. The cause of the pain is the skin incision, the carbon dioxide insufflation given into the abdomen for laparoscopy, and the visceral peritoneum.
This pain that occurs in the postoperative period negatively affects the patient's early mobilization, wound healing, and patient comfort. While the toxic effects of nonsteroids used for pain control on the liver and kidneys are known, narcotic analgesics have side effects such as nausea, vomiting, and addiction. In recent years, trunk blocks have begun to be used frequently for pain control in abdominal surgery. Although blocks such as erector spina plane (ESP), paravertebral (PVB), and transverses abdominis plane (TAP) are frequently applied, there are differences in terms of their effectiveness. On the other hand, it is important to give the patient a suitable position for the application.
Modified-thoracoabdominal nerve block (M-TAPA), which is applied especially in the supine position and is easier to apply compared to other blocks, has started to be applied as an alternative method.
In our study, we aimed to compare the effectiveness the MTAPA block compared to other trunk blocks such as ESP.
- Conditions
- Postoperative Analgesia
- Being tested
- M TAPA block, ESP block group
- Keywords
- laparoscopic cholecystectomy, MTAPA block, ESP block, postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M TAPA blockProcedure or surgery
Grup M: The patients who underwent M-TAPA block were placed in the supine position. The right upper quadrant of the abdomen was cleaned with antiseptic solution. For the block procedure, 30 ml of 0.25% bupivacaine, 22G 8.5 cm stimuplex needle and 10-14 Hz high frequency USG were prepared for the procedure. The USG probe was determined in the costochondral area at the mid-clavicular line, and the internal and transversus abdominis muscles were determined. The needle was advanced with the in plane technique from cephalad to caudal, passing through the skin, subcutaneous, external and internal oblique muscles, respectively, and then over the transversus abdominis fascia. After the target was confirmed with 2 ml of saline,30 ml local anestetic solution was administered.
ESP block groupProcedure or surgery
In Group E, patients who were to undergo ESP block were placed in the lateral position with the right side up. The T8-T10 dorsal region was cleaned appropriately with antiseptic solution. For the block procedure, 30cc %0.25 bupivacaine, 22G 8.5cm stimuplex needle and 10-14Hz high frequency USG were prepared for the procedure.
The USG probe is first determined in the sagittal direction, the spinous process of the T8-T10 thoracic vertebra is then followed 1-2 cm above the transverse process, with the in plane technique, the skin, subcutaneous tissue and erector spina muscle are passed, the needle is touched to the transverse process and the target is confirmed with 2cc saline, then 30 cc of local anesthetic is administered and the procedure is terminated.
| Study group | Role | What they receive |
|---|---|---|
| Group M: right-sided unilateral M-TAPA | Active comparator | M TAPA applied group Receives: Procedure: M TAPA block |
| Group E: right-sided unilateral ESP | Active comparator | ESB applied Group Receives: Procedure: ESP block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores
Numerical pain score ≥4
Measured: postoperative 24 hours
Secondary outcomes (3)
Postoperative opioid consumption
Total postoperative opioid consumption on 24.hours
Measured: 24 hours
Postoperative adverse effect
Shoulder pain
Measured: 6 hours
Postoperative adverse effect
Nausea and vomitting
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start15 Aug 2023
- Primary completion15 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muharrem Baturu, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660966
- Sponsor's protocol ID
- ANST01
- Acronym
- MTAPA and ESP
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. The successful usage of modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) for analgesia of laparoscopic ventral hernia repair. J Clin Anesth. 2019 Nov;57:1-2. doi: 10.1016/j.jclinane.2019.02.016. Epub 2019 Mar 1. No abstract available.
PubMed 30831469Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available.
PubMed 31212124Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.
PubMed 36307755
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of M TAPA Block and ESP Block in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06660966
- Acronym / sponsor ID
- MTAPA and ESP / ANST01
- Conditions
- Postoperative Analgesia
- Keywords
- laparoscopic cholecystectomy, MTAPA block, ESP block, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 28 Oct 2024 (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.
After cholecystectomy, modified-thoracoabdominal nerve block (M-TAPA) is a newly applied technique in upper abdominal surgery for postoperative analgesia. In recent years, block methods such as erector spina plane (ESP), paravertebral (PVB), transverses abdominis plane (TAP) have also been applied in these surgeries. MTAPA has been defined as a technique that is performed in the supine position and is easier to apply than the other mentioned blocks. In our study, we aimed to investigate the effectiveness of this block.
Detailed description
After laparoscopic cholecystectomy, most patients experience moderate to severe pain, especially in the first 24 hours. The cause of the pain is the skin incision, the carbon dioxide insufflation given into the abdomen for laparoscopy, and the visceral peritoneum.
This pain that occurs in the postoperative period negatively affects the patient's early mobilization, wound healing, and patient comfort. While the toxic effects of nonsteroids used for pain control on the liver and kidneys are known, narcotic analgesics have side effects such as nausea, vomiting, and addiction. In recent years, trunk blocks have begun to be used frequently for pain control in abdominal surgery. Although blocks such as erector spina plane (ESP), paravertebral (PVB), and transverses abdominis plane (TAP) are frequently applied, there are differences in terms of their effectiveness. On the other hand, it is important to give the patient a suitable position for the application.
Modified-thoracoabdominal nerve block (M-TAPA), which is applied especially in the supine position and is easier to apply compared to other blocks, has started to be applied as an alternative method.
In our study, we aimed to compare the effectiveness the MTAPA block compared to other trunk blocks such as ESP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M: right-sided unilateral M-TAPA | Active comparator | Procedure: M TAPA blockM TAPA applied group |
| Group E: right-sided unilateral ESP | Active comparator | Procedure: ESP block groupESB applied Group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III ,
- 18-70 yaş,
- Elective surgery
Key exclusion criteria (6 listed)
- Pregnancy,
- Patient with emegency,
- Patients allergic to local anesthetics,
- Patient with coagulopaty,
- Uncooperative, mentally retarded patients
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 |
|---|---|---|
| M TAPA blockGrup M: The patients who underwent M-TAPA block were placed in the supine position. The right upper quadrant of the abdomen was cleaned with antiseptic solution. For the block procedure, 30 ml of 0.25% bupivacaine, 22G 8.5 cm stimuplex needle and 10-14 Hz high frequency USG were prepared for the procedure. The USG probe was determined in the costochondral area at the mid-clavicular line, and the internal and transversus abdominis muscles were determined. The needle was advanced with the in plane technique from cephalad to caudal, passing through the skin, subcutaneous, external and internal oblique muscles, respectively, and then over the transversus abdominis fascia. After the target was confirmed with 2 ml of saline,30 ml local anestetic solution was administered. | Procedure or surgery | Group M: right-sided unilateral M-TAPA |
| ESP block groupIn Group E, patients who were to undergo ESP block were placed in the lateral position with the right side up. The T8-T10 dorsal region was cleaned appropriately with antiseptic solution. For the block procedure, 30cc %0.25 bupivacaine, 22G 8.5cm stimuplex needle and 10-14Hz high frequency USG were prepared for the procedure. The USG probe is first determined in the sagittal direction, the spinous process of the T8-T10 thoracic vertebra is then followed 1-2 cm above the transverse process, with the in plane technique, the skin, subcutaneous tissue and erector spina muscle are passed, the needle is touched to the transverse process and the target is confirmed with 2cc saline, then 30 cc of local anesthetic is administered and the procedure is terminated. | Procedure or surgery | Group E: right-sided unilateral ESP |
Primary outcome
Postoperative pain scores
Time frame: postoperative 24 hours
Numerical pain score ≥4
3 secondary outcomes
Postoperative opioid consumption
Time frame: 24 hours
Postoperative adverse effect
Time frame: 6 hours
Postoperative adverse effect
Time frame: 24 hours
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 2 Nov 2026.
- Results publication: PubMed 30831469Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. The successful usage of modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) for analgesia of laparoscopic ventral hernia repair. J Clin Anesth. 2019 Nov;57:1-2. doi: 10.1016/j.jclinane.2019.02.016. Epub 2019 Mar 1. No abstract available.
- Results publication: PubMed 31212124Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available.
- Results publication: PubMed 36307755Bilge A, Basaran B, Et T, Korkusuz M, Yarimoglu R, Toprak H, Kumru N. Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial. BMC Anesthesiol. 2022 Oct 28;22(1):329. doi: 10.1186/s12871-022-01866-4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M TAPA block and ESP block group in people with Postoperative Analgesia, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 2 Nov 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 Turkey (Türkiye). 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?
Postoperative pain scores (time frame: postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06660966, which also lists 3 linked publications.
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 2 Nov 2026.