Effects of Fascial Plan Blocks on Pulmonary Functions

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06144307
• Other study ID #: 2023/04-3
• Status: Active, not recruiting
• Start date: October 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Zonguldak Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Respiratory Function Loss

Intervention

Procedure:
• plane block
injection of local anesthetic to the myofascial plane

Locations

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

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	the effect of plane blocks on postoperative pulmonary function	The effect of pain relief after plane blocks on postoperative pulmonary function	during the postoperative 24 hours
Secondary	opioid consumption	need for opioids as a result of pain	during the postoperative 24 hours
Secondary	Incidence of nausea and vomiting	Need for nausea and vomiting	during the postoperative 24 hours
Secondary	quality of recovery-15	Quality of recovery of patients by survey	during the postoperative 24 hours