Combined SAPB in MICS

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pain; Serratus Anterior Plane Block; Postoperative Analgesia; Minimal Invasive Cardiac Surgery
• Intervention / Treatment: Procedure: Combined SAPB

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emine Nilgün N Zengin, MD; Phone Number: +905063370548; Email: nilbavullu@gmail.com
• Study Contact Backup: Name: Nevriye Salman, MD; Phone Number: 00905334206834; Email: nevriyes@hotmail.com

Study Locations

• Turkey
  • Ankara
    • Çankaya, Ankara, Turkey, 06290
      • Recruiting
      • Ankara City Hospital
      • Contact: Emine N Zengin, MD; Phone Number: +905063370548; Email: nilbavullu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Combined serratus anterior plane block; Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique beneath the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area. Then, with the same needle, will be returned 1-2 cm from the deep serratus anterior area to superficial serratus anterior area above the serratus anterior muscle and will be injected 2 ml normal saline for hydrodissection. Finally 20ml of 0.25% bupivacaine will be injected for superficial serratus anterior block into the interfacial area.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remifentanyl Consumption	Remifentanyl consumption for intraoperative period will be recorded	intraoperative period

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Estimated): May 7, 2024
• Study Completion (Estimated): May 17, 2024

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: March 17, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: E.Kurul-E2-24-6175

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No