Effects of M-TAPA Block on Pulmonary Functions

Obesity, Morbid Clinical Trial

Official title:

Effects of M-TAPA Block on Postoperative Pulmonary Functions in Laparoscopic Bariatric Surgery: A Randomized Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06148597
• Other study ID #: 2023/04-4
• Status: Active, not recruiting
• Start date: October 20, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: January 2024
• Source: Zonguldak Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: May 20, 2024
• Est. primary completion date: April 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid
• Pain Management
• Pulmonary Functions

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Turkey	Zonguldak Bülent Ecevit University Medicine Faculty	Zonguldak	Kozlu

Sponsors (1)

Lead Sponsor	Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1/FVC ratio	Pulmonary function	during the procedure
Secondary	Numerical Rating Scale	pain assessment tool (minimum: 0, maximum: 10)	during the procedure
Secondary	opioid consumption	need of opioid postoperatively	24 hours after surgery