- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05160155
Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block
January 7, 2023 updated by: Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block for Rib Fractures
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ankara
-
Kecioren, Ankara, Turkey, 06000
- Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Serratus anterior plane block will be performed unilaterally, under US guidance.
|
Active Comparator: 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.
|
Intercostal Block will be performed unilaterally, under US guidance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain scores
Time Frame: 24 hours after block
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Need for additional analgesia
Time Frame: 24 hours after block
|
Whether the patients need additional analgesia after the block and the amount of additional analgesia needed will be recorded.
|
24 hours after block
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 3, 2021
Primary Completion (Actual)
December 20, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
December 3, 2021
First Submitted That Met QC Criteria
December 3, 2021
First Posted (Actual)
December 16, 2021
Study Record Updates
Last Update Posted (Estimate)
January 10, 2023
Last Update Submitted That Met QC Criteria
January 7, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E.Kurul-E1-21-2143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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