- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06144307
Effects of Fascial Plan Blocks on Pulmonary Functions
Effects of External Oblique Fascial Plan Block and Subcostal Transversus Abdominis Plan Block on Postoperative 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Zonguldak
-
Kozlu, Zonguldak, Turkey, 67600
- Zonguldak Bülent Ecevit University Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control
|
|
|
External Oblique Fascial Plan Block
|
injection of local anesthetic to the myofascial plane
|
|
Subcostal Transversus Abdominis Plan Block
|
injection of local anesthetic to the myofascial plane
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
during the postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
opioid consumption
Time Frame: during the postoperative 24 hours
|
need for opioids as a result of pain
|
during the postoperative 24 hours
|
|
Incidence of nausea and vomiting
Time Frame: during the postoperative 24 hours
|
Need for nausea and vomiting
|
during the postoperative 24 hours
|
|
quality of recovery-15
Time Frame: during the postoperative 24 hours
|
Quality of recovery of patients by survey
|
during the postoperative 24 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/04-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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