Pulmonary FunctionsNCT06148597
Effects of M-TAPA Block on Pulmonary Functions
An observational study of Pulmonary Functions and Pain Management, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Adequate postoperative analgesia is difficult to achieve in patients undergoing laparoscopic sleeve gastrectomy (LSG). Epidural anesthesia is technically difficult due to subcutaneous fat, which increases the risk of serious complications. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Functions, Pain Management, Obesity, Morbid
- What is being tested?
- Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA)
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Jul 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18-65 who will undergo ASA I-III laparoscopic bariatric surgery
Who may be able to join
- Between 18-65 years old
- ASA I-II-III risk group
- Patients whose approval was obtained through an informed consent form
- Will undergo laparoscopic bariatric surgery
- Patients who will cooperate for the PFT test
Who cannot join
- <18 years and >65 years
- ASA ≥ IV
- 50% below the expected value in SFT
- Known diaphragmatic paralysis
- Having had a myocardial infarction within 1 month
- Dementia or confusion
Show all 11Show fewer
- Lack of cooperation
- Those with respiratory disease
- Congestive heart failure
- Unstable hypertension
- Had thoracoabdominal surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, 67600
About this study
Official title: Effects of M-TAPA Block on Postoperative Pulmonary Functions in Laparoscopic Bariatric Surgery: A Randomized Controlled Study
Adequate postoperative analgesia is difficult to achieve in patients undergoing laparoscopic sleeve gastrectomy (LSG). Epidural anesthesia is technically difficult due to subcutaneous fat, which increases the risk of serious complications. Moreover, patients in this condition often have comorbidities that require anticoagulation therapy. Although ultrasound-guided Transversus Abdominis Plane (TAP) block may be useful, it is still controversial.
Recently, modified thoracoabdominal nerve block via perichondrial approach (M-TAPA) has been reported as a new and promising technique that provides effective analgesia in the anterior and lateral thoracoabdominal wall.
Read more
The most common reason for hospitalization after laparoscopic surgery is pain after nausea and vomiting. In addition, superficial and tachypneic breathing resulting from the patient's inability to breathe deeply with pain causes closure of small airways and increase in intrapulmonary shunts, resulting in hypoxia. Postoperative pain management is important not only to prevent pain but also to reduce pulmonary complications that may occur due to changes in lung function and to reduce mortality and morbidity by controlling the stress response.
In this study, The investigators investigated the effect of modified thoracoabdominal nerve block via perichondrial approach (M-TAPA) on pulmonary function in patients undergoing laparoscopic bariatric surgery under general anesthesia.
- Conditions
- Pulmonary Functions, Pain Management, Obesity, Morbid
- Being tested
- Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA)
- Keywords
- obesity, pain management, pulmonary functions, respiratory function test
- Medical subject headings
- Agnosia, Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA)Procedure or surgery
application local anesthetic between internal oblique and transversus abdominis muscle at the level of 10th costal cartilage
| Study group | Role | What they receive |
|---|---|---|
| Group M-TAPA | Not described Receives: Procedure: Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) | |
| Group Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1/FVC ratio
Pulmonary function
Measured: during the procedure
Secondary outcomes (2)
Numerical Rating Scale
pain assessment tool (minimum: 0, maximum: 10)
Measured: during the procedure
opioid consumption
need of opioid postoperatively
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Dec 2023
- Primary completion30 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FunctionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağdaş Baytar, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148597
- Sponsor's protocol ID
- 2023/04-4
- Status last verified
- Apr 2025
- First submitted
- 20 Nov 2023
- Last updated
- 22 Apr 2025
- 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 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of M-TAPA Block on Postoperative Pulmonary Functions in Laparoscopic Bariatric Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06148597
- Acronym / sponsor ID
- 2023/04-4
- Conditions
- Pulmonary Functions, Pain Management, Obesity, Morbid
- Keywords
- obesity, pain management, pulmonary functions, respiratory function test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 28 Nov 2023 (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.
Adequate postoperative analgesia is difficult to achieve in patients undergoing laparoscopic sleeve gastrectomy (LSG). Epidural anesthesia is technically difficult due to subcutaneous fat, which increases the risk of serious complications. Moreover, patients in this condition often have comorbidities that require anticoagulation therapy. Although ultrasound-guided Transversus Abdominis Plane (TAP) block may be useful, it is still controversial.
Recently, modified thoracoabdominal nerve block via perichondrial approach (M-TAPA) has been reported as a new and promising technique that provides effective analgesia in the anterior and lateral thoracoabdominal wall.
The most common reason for hospitalization after laparoscopic surgery is pain after nausea and vomiting. In addition, superficial and tachypneic breathing resulting from the patient's inability to breathe deeply with pain causes closure of small airways and increase in intrapulmonary shunts, resulting in hypoxia. Postoperative pain management is important not only to prevent pain but also to reduce pulmonary complications that may occur due to changes in lung function and to reduce mortality and morbidity by controlling the stress response.
In this study, The investigators investigated the effect of modified thoracoabdominal nerve block via perichondrial approach (M-TAPA) on pulmonary function in patients undergoing laparoscopic bariatric surgery under general anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M-TAPA | – | Procedure: Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) |
| Group Control | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 who will undergo ASA I-III laparoscopic bariatric surgery
Key inclusion criteria (5 listed)
- Between 18-65 years old
Key exclusion criteria (11 listed)
- <18 years and >65 years
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 |
|---|---|---|
| Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA)application local anesthetic between internal oblique and transversus abdominis muscle at the level of 10th costal cartilage | Procedure or surgery | Group M-TAPA |
Primary outcome
FEV1/FVC ratio
Time frame: during the procedure
Pulmonary function
2 secondary outcomes
Numerical Rating Scale
Time frame: during the procedure
opioid consumption
Time frame: 24 hours after surgery
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 2025.
- 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.
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?
An observational study of Pulmonary Functions and Pain Management, run by Zonguldak Bulent Ecevit University 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 5 inclusion and 11 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 2025. 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?
FEV1/FVC ratio (time frame: during the procedure). 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 2025.