Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures

Not Applicable

Not yet recruiting

• Conditions: Rib Fractures; Spirometry
• Interventions: Procedure: Serratus plane block (continuous or single-shot)

• Registration Number: NCT05105399
• Lead Sponsor: Niguarda Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-09
• Study Start: 2024-06-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Chest trauma with at least 2 monolateral rib fractures (monofocal or multifocal) with no flail chest
2. Age>18 years
3. Hospital admission
4. Ability to provide written informed consensus
5. Awake patient, spontaneous ventilation

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single	Serratus plane block (continuous or single-shot)	-
Continuous	Serratus plane block (continuous or single-shot)	-

Primary Outcome Measures

Name	Time	Method
FEV1 (% of the predicted value)	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

Trial Locations

Locations (1)

ASST GOM Niguarda; 🇮🇹 Milano, Italy