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Clinical Trials/NCT05105399
NCT05105399Not yet recruitingNot Applicable

Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures: a Perspective Randomized Controlled Study

Niguarda Hospital2 sites in 1 country72 target enrollmentStarted: June 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
72
Locations
2
Primary Endpoint
FEV1 (% of the predicted value)

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Morphine

No Intervention

Continuous

Active Comparator

Intervention: Serratus plane block (continuous or single-shot) (Procedure)

Single

Active Comparator

Intervention: Serratus plane block (continuous or single-shot) (Procedure)

Outcomes

Primary Outcomes

FEV1 (% of the predicted value)

Time Frame: 72 hours

Any statistically significant difference between the two treatment groups and the control group will be measured. FEV1 is expected to be respectively 80±15% of the predicted value in the treatment groups and 64±15% of the predicted value in the control group

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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