Serratus Anterior Plan Block and Postoperative Pain in Patients Who Underwent Minimally Invasive Cardiac Surgery

NCT06002867 | Completed

• 1 other identifier: 2022/16-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Acute postoperative pain is defined as sudden onset pain that develops after stimulation due to surgical intervention. It is most severe in the first 24 hours after surgery and gradually decreases in severity and creates dissatisfaction in the patient. Postoperative pain that cannot be treated properly can cause various systemic effects, prolongation of hospital stay, decrease in patients' quality of life, and development of chronic pain. An increase in blood pressure, heart rate, cardiac irritability and systemic vascular resistance is observed with the sympathetic response due to pain. Increased myocardial workload and oxygen consumption may increase or trigger myocardial ischemia. Pulmonary dysfunction has an important place in the determination of mortality and morbidity after surgery and anesthesia.Especially in patients who have undergone thoracic surgery, pain limits the movements of the thoracic muscles, reducing functional residual capacity and vital capacity.This causes the development of atelectasis in the patient and the development of hypoxia and pneumonia due to the deterioration of the ventilation/perfusion ratio. Effective analgesia can be achieved in the postoperative period by administering a certain volume of local anesthetic between any two muscle planes using USG. In SAPB, a local anesthetic is injected between the serratus anterior muscle and the latissimus dorsi muscle to create sensory paresthesia in the thoracic wall. It is known to reduce pain scores in the postoperative period. Serratus anterior plane block is a safe facial plane block performed under USG guidance.Depending on the application site of the block and the amount of local anesthetic administered, different numbers of intercostal nerves, long thoracic nerves and thoracodorsal nerves may be affected. The fact that Serratus anterior plane block (SAPB) is effective between T2-T9 dermatomes enables it to be used effectively in lateral thoracic wall surgeries.

Conditions

Morphine Consumption; Pain

Keywords

Serratus anterior plan block; Postoperative Pain; Minimally Invasive Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Morphine consumption by PCA (Patient Control Analgesia)

  Morphine consumption used in case of pain

  The change from baseline in the postoperative period at the 1, 2, 4, 8, 12 and 24th hour after extubation

Secondary Outcomes (5)

• pain (NRS)score

  Change from baseline of NRS Score at 1,2, 4,,8, 12 and 24 hours after being extubated will be recorded.

• PH

  Change from baseline of PH at the 1, 2, 4, 8, 12 and 24th hour after extubation

• PO2

  Change from baseline of PO2 at the 1, 2,4 , 8, 12 and 24th hour after extubation

• Mean Arterial Pressure (MAP)

  Change from baseline of MAP at the 1, 2, 4, 8, 12 and 24th hour after extubation

• PCO2

  Change from baseline of PCO2 change at the 1, 2, 4, 8, 12 and 24th hour after extubation

Study Arms (2)

Group SAPB (Serratus anterior plane block)

ACTIVE COMPARATOR

Active Comparator: Group SAPB (Serratus anterior plane block) After the operation is completed, the block operation will be performed while intubated. The patient will be in the supine position. The area where the procedure will be performed will be cleaned with povidone iodine. The latissimus dorsi muscle and the serratus muscle will be visualized at the level of the 4th and 5th ribs using a 22-gauge, 80 mm insulated Quincke type needle with the 'in plane' technique, accompanied by a high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath. . After the fascia between the two muscles is fixed, the block needle will be advanced from caudal to cranial and 40 ml (20 ml local anesthetic + 20 ml saline) 0.25% local anesthetic will be injected on the serratus muscle between the two muscles.

Procedure: SAPB (Serratus Anterior Plan) Block

Group Control

NO INTERVENTION

The action will not be applied

Interventions

SAPB (Serratus Anterior Plan) Block PROCEDURE

The patient will be in the supine position. The area where the procedure will be performed will be cleaned with povidone iodine. Using a 22-gauge, 80 mm insulated Quincke needle with a high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath, the latissimus dorsi muscle and the serratus muscle will be visualized at the level of the 4th and 5th ribs. After determining the fascia between the two muscles, the block needle will be advanced from caudal to cranial and 40 ml of 0.25% bupivacaine (local anesthetic) will be injected on the serratus muscle between the two muscles.

Group SAPB (Serratus anterior plane block)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-65,
• Coronary artery patients with normal left ventricular function and scheduled for elective coronary artery bypass surgery,
• Valve diseases for which elective valve replacement is planned with normal left ventricular function,
• Cases of ASD (Atrial Septal Defect) for atrial septal defect closure
• Patients who will have elective valve + coronary artery bypass without left ventricular dysfunction and patients who volunteer to participate in the study,
• No coagulation disorder
• Patients with a platelet count of more than 100,000,
• Patients with good mental status,
• Patients with an ejection difference value (E/F) above 50% will be included in the study.

You may not qualify if:

• Cases that will require emergency and repeat heart surgery,
• With advanced left coronary artery disease and left ventricular dysfunction,
• Receiving preoperative inotropic support therapy for any reason,
• Mitral stenosis with atrial thrombus,
• Patients with low cardiac out put syndrome and E/F below 50%,
• Patients who need intra-aortic balloon pump during surgery,
• Patients with bleeding and coagulation disorders,
• Patients with hepatic and renal dysfunction,
• Patients with Uncontrolled Diabetes Mellitus and Chronic Obstructive Pulmonary Disease,
• Patients allergic to opioids, analgesics and bupivacaine,
• Patients with atrial fibrillation using anticoagulants,
• Patients with cognitive dysfunction
• Patients who do not want to participate in the study will be excluded from the study.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University Faculty of Medicine

Kahramanmaraş, 46040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Saposins; Dental Occlusion

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Sphingolipid Activator Proteins; Coenzymes; Enzymes and Coenzymes; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Yavuz Orak

  Kahramanmaraş Sütçü İmam Üniversitesi Tıp Fakültesi, Anesteziyoloji ve Reanimasyon Bölümü

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Grup SAPB Grup Control

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: August 21, 2023
• Study Start: September 1, 2023
• Primary Completion: February 15, 2024
• Study Completion: April 10, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)