Effects of M-TAPA Block on Pulmonary Functions

Sponsor

Zonguldak Bulent Ecevit University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06148597

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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, we 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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Functions Pain Management Obesity, Morbid	Procedure: Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA)

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 20, 2023

Anticipated Primary Completion Date :

Apr 20, 2024

Anticipated Study Completion Date :

May 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Group M-TAPA	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
Group Control

Arm

Intervention/Treatment

Group M-TAPA

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

Group Control

Outcome Measures

Primary Outcome Measures

FEV1/FVC ratio [during the procedure]
Pulmonary function

Secondary Outcome Measures

Numerical Rating Scale [during the procedure]
pain assessment tool
opioid consumption [24 hours after surgery]
need of opioid postoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zonguldak Bülent Ecevit University Medicine Faculty	Zonguldak	Kozlu	Turkey	67600

Sponsors and Collaborators

Zonguldak Bulent Ecevit University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Çağdaş Baytar, medical doctor, Zonguldak Bulent Ecevit University

ClinicalTrials.gov Identifier:

NCT06148597

Other Study ID Numbers:

2023/04-4

First Posted:

Nov 28, 2023

Last Update Posted:

Nov 28, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Çağdaş Baytar, medical doctor, Zonguldak Bulent Ecevit University

obesity

pain management

pulmonary functions

respiratory function test

Additional relevant MeSH terms:

Obesity, Morbid

Study Results

No Results Posted as of Nov 28, 2023