- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06148597
Effects of M-TAPA Block on Pulmonary Functions
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kozlu
-
Zonguldak, Kozlu, Turkey, 67600
- Zonguldak Bülent Ecevit University Medicine Faculty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
<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
- Lack of cooperation
- Those with respiratory disease
- Congestive heart failure
- Unstable hypertension
- Had thoracoabdominal surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group Control
|
|
|
Group M-TAPA
|
application local anesthetic between internal oblique and transversus abdominis muscle at the level of 10th costal cartilage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FEV1/FVC ratio
Time Frame: during the procedure
|
Pulmonary function
|
during the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
opioid consumption
Time Frame: 24 hours after surgery
|
need of opioid postoperatively
|
24 hours after surgery
|
|
Numerical Rating Scale
Time Frame: during the procedure
|
pain assessment tool (minimum: 0, maximum: 10)
|
during the procedure
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/04-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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