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OpenTrials
Completed

NCT Number: NCT06144307

Effects of Fascial Plan Blocks on Pulmonary Functions

In addition to the traumatic effect of the operation, the effort to immobilize the auxiliary respiratory muscles due to pain causes a decrease in postoperative respiratory function (especially in thoracic and upper abdominal surgeries). In addition, superficial and tachypneic breathing caused by the inability of the patient to take deep breaths with pain leads to 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. Pain after nausea and vomiting is the most common reason for hospitalization after laparoscopic surgery.

Although pain in laparoscopic cholecystectomy (LC) has many components including incisional, visceral and reflected, the primary source of pain is incisional pain. A multimodal analgesic approach (NSAII, paracetamol, opioids, local infiltration, facial plane blocks and paravertebral and periparavertebral blocks) is recommended. Regional anesthesia combined with general anesthesia reduces the stress response associated with surgery and reduces the need for opioid use. Subcostal TAP Block; injection of local anesthetic between the internal oblique and transversus abdominis muscles in the upper quadrant of the anterior abdominal wall blocks the anterior cutaneous branches of the thoracoabdominal nerves. External Oblique Fascial Plane Block (EOIB); blocks both the anterior and lateral cutaneous branches of the thoracoabdominal nerves. It is performed between the 6th-7th costae. There is a cutaneous sensory block between T6-T9 in the midabdomen and T6-T10 in the anterior axillary line.

The conventional method is the administration of intravenous opioids as a method of postoperative analgesia when the routine block cannot be performed due to a contraindication.

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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 Faculty of Medicine

Kozlu, Zonguldak Province, 67600, Turkey (Türkiye)

Who can participate

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

Inclusion criteria

  • 18-65 years old
  • ASA I-II-III risk group
  • Patients whose consent was obtained with an informed consent form
  • She will undergo a cholecystectomy operation
  • Patients to be cooperative for SFT test

Exclusion criteria

  • <18 years and >65 years
  • ASA ≥ IV
  • Pulmonary function test below 50% of the expected value
  • Known diaphragm paralysis
  • Body mass index >30
  • Myocardial infarction within 1 month
  • Dementia or confusion
  • Lack of cooperation
  • People with respiratory diseases
  • Congestive heart failure
  • Unstable hypertension
  • Thoracoabdominal surgery

Treatment and study plan

plane block

Procedure

injection of local anesthetic to the myofascial plane

Primary outcomes

  1. the effect of plane blocks on postoperative pulmonary function

    Time frame: during the postoperative 24 hours

    The effect of pain relief after plane blocks on postoperative pulmonary function

Secondary outcomes

  1. opioid consumption

    Time frame: during the postoperative 24 hours

    need for opioids as a result of pain

  2. Incidence of nausea and vomiting

    Time frame: during the postoperative 24 hours

    Need for nausea and vomiting

  3. quality of recovery-15

    Time frame: during the postoperative 24 hours

    Quality of recovery of patients by survey

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

Effects of External Oblique Fascial Plan Block and Subcostal Transversus Abdominis Plan Block on Postoperative Pulmonary Functions

Important dates

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