Combined SAPB in MICS

Acute Pain Clinical Trial

Official title:

The Effects of Combined Serratus Anterior Plane Block on Postoperative Acute Pain After Minimally Invasive Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326320
• Other study ID #: E.Kurul-E2-24-6175
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2024
• Est. completion date: May 17, 2024

Study information

• Verified date: March 2024
• Source: Ankara City Hospital Bilkent
• Contact: Emine Nilgün N Zengin, MD
• Phone: +905063370548
• Email: nilbavullu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Minimally invasive cardiac surgery (MICS) has begun to be performed frequently in recent years. Compared to sternotomy, MISC reduces the risk of mediastinitis, leaves a more aesthetic scar, facilitates postoperative rehabilitation, and shortens the hospital stay. MICS requires a thoracic incision in the right 4th or 5th intercostal space. This incision causes intense and long-lasting pain in the postoperative period. Pain is exacerbated by breathing movements, coughing, and respiratory physiotherapy.

Postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in any type of cardiothoracic surgery. If patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. This prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity.

In addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. In recent years, thoracic epidural analgesia has been avoided due to the use of intraoperative high-dose heparin. As an alternative, peripheral nerve blocks have recently gained popularity. SAPB is one of them. SAPB can be applied in three ways. While deep SAPB (DSAPB) is applied under the serratus anterior muscle, superficial SAPB (SSAPB) is applied above the serratus anterior muscle. Combined SAPB (CSAPB) is applied both below and above the serratus anterior muscle. These blocks can be performed with a single injection anywhere between the second and seventh ribs on the lateral chest wall.

In this study, the analgesic effects of ultrasound-guided CSAPB application in patients undergoing MICS will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 17, 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18 to 80 years old

• American Society of Anesthesiologists (ASA) physical status I-II-III

• BMI 18 to 40 kg/m2

• Elective Minimally Invasive Cardiac Surgery (MICS)

Exclusion Criteria:

• Patient refusing the procedure

• Emergency surgery

• History of chronic opioid or analgesic used

Related Conditions & MeSH terms

• Acute Pain
• Postoperative Analgesia
• Serratus Anterior Plane Block

Intervention

Procedure:
• Combined SAPB
Combined Deep and Superficial Serratus Anterior Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the supine position. 40 ml of 0.25% bupivacaine will be used in applications.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Çankaya	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores	After the extubation, pain will be assessed for the sternum and the drain area at the 0th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	0th hour the extubation
Primary	Pain Scores	After the extubation, pain will be assessed for the sternum and the drain area at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	2nd hour the extubation
Primary	Pain Scores	After the extubation, pain will be assessed for the sternum and the drain area at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	4th hour the extubation
Primary	Pain Scores	After the extubation, pain will be assessed for the sternum and the drain area at the 8th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	8th hour the extubation
Primary	Pain Scores	After the extubation, pain will be assessed for the sternum and the drain area at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	12th hour the extubation
Secondary	Remifentanyl Consumption	Remifentanyl consumption for intraoperative period will be recorded	intraoperative period