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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05160155
Other study ID # E.Kurul-E1-21-2143
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 3, 2021
Est. completion date December 30, 2022

Study information

Verified date January 2023
Source Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 30, 2022
Est. primary completion date December 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Procedure:
Serratus Anterior Plane Block
Serratus anterior plane block will be performed unilaterally, under US guidance.
Intercostal Block
Intercostal Block will be performed unilaterally, under US guidance.

Locations

Country Name City State
Turkey Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital Kecioren Ankara

Sponsors (1)

Lead Sponsor Collaborator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Need for additional analgesia Whether the patients need additional analgesia after the block and the amount of additional analgesia needed will be recorded. 24 hours after block
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