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Completed

NCT Number: NCT06148597

Effects of M-TAPA Block on Pulmonary Functions

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. FEV1/FVC ratio

    Time frame: during the procedure

    Pulmonary function

Secondary outcomes

  1. Numerical Rating Scale

    Time frame: during the procedure

    pain assessment tool (minimum: 0, maximum: 10)

  2. opioid consumption

    Time frame: 24 hours after surgery

    need of opioid postoperatively

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2023
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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