Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Serratus plane block (continuous or single-shot).
- Who it may be relevant to
- Registry conditions: Rib Fractures, Spirometry. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures: a Perspective Randomized Controlled Study
Overview
In patients admitted following a trauma, the incidence of multiple rib fractures is reported to be 9,7%, and this can be even higher in high energy trauma like motor vehicle accidents (1). Pain deriving from rib fractures cause the patient to breath shallow in order to limit discomfort and this bring about negative consequences: shallow breathing and inability to clear secretions may cause pulmonary atelectasis eventually evolving to pneumonia. Given the aforementioned concerns, it is easy to understand why, in a context like this, control of chest pain become crucial. The best way to achieve adequate pain control have not yet been established: the aim of this study is to investigate on this clinical dilemma. In this study, 72 people with at least two monolateral rib fractures are going to be randomized into three groups: 1) standard treatment alone (intravenous analgesia: acetaminophen + morphine PCA); 2) continuous serratus plane block + standard treatment; 3) single-shot serratus plane block + standard treatment. The variables that are going to be recorded are the following: pain through the NRS scale, FEV1 and FVC through spirometry and finally an arterious gas analysis. Recording are going to be repeated at 72h after admission. The primary endpoint is to evaluate if the continuous serratus plane block is able to improve the FEV1/FVC compared to single shot or standard treatment alone. Secondary endpoints will be: the effect of continuous block on 1) resting and incident pain; 2) opioid consumption; 3) blood gas analysis parameters; 4) pulmonary complications at 1 month; 5) length of stay
Interventions
- Procedure Serratus plane block (continuous or single-shot)
Patients assigned to the interventional arms will receive either continuous serratus plane block or single-shot serratus plane block
Primary outcome measures
- FEV1 (% of the predicted value) [Time frame: 72 hours]
Eligibility criteria
Inclusion criteria
- Chest trauma with at least 2 monolateral rib fractures (monofocal or multifocal) with no flail chest
- Age>18 years
- Hospital admission
- Ability to provide written informed consensus
- Awake patient, spontaneous ventilation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- ASST GOM Niguarda — Milan
Identifiers
NCT: NCT05105399 · SAP Versione 2 del 05/06/2020