Effects of M-TAPA Block on Pulmonary Functions

NCT06148597 | Completed

• 1 other identifier: 2023/04-4
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pulmonary Functions; Pain Management; Obesity, Morbid

Keywords

obesity; pain management; pulmonary functions; respiratory function test

Outcome Measures

Primary Outcomes (1)

• FEV1/FVC ratio

  Pulmonary function

  during the procedure

Secondary Outcomes (2)

• Numerical Rating Scale

  during the procedure

• opioid consumption

  24 hours after surgery

Study Arms (2)

Group M-TAPA

Procedure: Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA)

Group Control

Interventions

Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) PROCEDURE

application local anesthetic between internal oblique and transversus abdominis muscle at the level of 10th costal cartilage

Group M-TAPA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18-65 who will undergo ASA I-III laparoscopic bariatric surgery

You may qualify if:

• 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

You may not qualify if:

• \<18 years and \>65 years
• ASA ≥ IV
• % 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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: December 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: July 1, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)