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

NCT05160155 | Completed

• 1 other identifier: E.Kurul-E1-21-2143
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain scores

  Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.

  24 hours after block

Secondary Outcomes (1)

• Need for additional analgesia

  24 hours after block

Study Arms (2)

Serratus Anterior Plane Block

ACTIVE COMPARATOR

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.

Procedure: Serratus Anterior Plane Block

Intercostal Block

ACTIVE COMPARATOR

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.

Procedure: Intercostal Block

Interventions

Serratus Anterior Plane Block PROCEDURE

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

Serratus Anterior Plane Block

Intercostal Block PROCEDURE

Intercostal Block will be performed unilaterally, under US guidance.

Intercostal 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:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: lead

Study Sites (1)

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rib Fractures; Acute Pain

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Musa Zengin, MD

  Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 16, 2021
• Study Start: December 3, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 30, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)