Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block

NCT ID: NCT05160155

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2022-12-30

Brief Summary

More than 50% of patients presenting with chest trauma experience rib fractures and these rib fractures are associated with significant morbidity, mortality, and long-term disability. Many of these adverse outcomes result from poorly controlled pain that interferes with breathing, leading to atelectasis, pneumonia, and respiratory failure. Therefore, early provision of adequate analgesia is crucial in the management of these patients. The basic stones of analgesic therapy are oral and intravenous drugs such as paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids. However, patients with more significant injuries or comorbidities often require interventional procedures to provide adequate analgesia and avoid opioid-related side effects. Thoracic epidural analgesia and thoracic paravertebral blocks have traditionally been used, but these techniques are associated with side effects and may cause hemodynamic instability. Today, the use of ultrasonography (USG) guided block techniques such as erector spinae plane block (ESPB), serratus anterior plane block (SAPB) and intercostal block (ICB) has increased. These techniques are considered to be simpler and theoretically safer. Although ICB is frequently mentioned in the literature, the publications of new plane blocks such as ESPB and SAPB are new and few in number. In this study, SAPB and ICP to be performed with USG will be evaluated in terms of analgesic effect.

Conditions

Rib Fractures; Serratus Anterior Plane Block; Erector Spinae Plane Block; Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Serratus Anterior Plane Block

Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique above 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. The block will be terminated.

Group Type: ACTIVE_COMPARATOR

Serratus Anterior Plane Block

Intervention Type: PROCEDURE

Serratus anterior plane block will be performed unilaterally, under US guidance.

Intercostal Block

The USG probe will be placed at the level of the posterior axillary line and the broken ribs. The ribs, external intercostal muscle, and internal intercostal muscle structures will be imaged. 3 ml of 0.25% bupivacaine will be injected into the subcostal area. This 3 ml 0.25% bupivacaine injection will be administered for each broken rib. The block will be terminated.

Group Type: ACTIVE_COMPARATOR

Intercostal Block

Intervention Type: PROCEDURE

Intercostal Block will be performed unilaterally, under US guidance.

Interventions

Serratus Anterior Plane Block

Serratus anterior plane block will be performed unilaterally, under US guidance.

Intervention Type: PROCEDURE

Intercostal Block

Intercostal Block will be performed unilaterally, under US guidance.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 65 years
• American Society of Anesthesiologists physical status I-II-III
• Body mass index between 18-30 kg/m2
• Patients with 6 or less rib fractures

Exclusion Criteria

• Patient refusing the procedure
• History of chronic analgesic or opioid therapy
• History of local anesthetic allergy
• Infection in the intervention area

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Musa Zengin

Principal İnvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Musa Zengin, MD

Role: PRINCIPAL_INVESTIGATOR

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Locations

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E.Kurul-E1-21-2143

Identifier Type: -

Identifier Source: org_study_id