Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures
Primary Purpose
Rib Fractures, Spirometry
Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Serratus plane block (continuous or single-shot)
Sponsored by
About this trial
This is an interventional treatment trial for Rib Fractures
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
Sites / Locations
- ASST GOM Niguarda
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Morphine
Continuous
Single
Arm Description
Outcomes
Primary Outcome Measures
FEV1 (% of the predicted value)
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 Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05105399
Brief Title
Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures
Official Title
Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures: a Perspective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niguarda Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures, Spirometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morphine
Arm Type
No Intervention
Arm Title
Continuous
Arm Type
Active Comparator
Arm Title
Single
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Serratus plane block (continuous or single-shot)
Intervention Description
Patients assigned to the interventional arms will receive either continuous serratus plane block or single-shot serratus plane block
Primary Outcome Measure Information:
Title
FEV1 (% of the predicted value)
Description
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
Time Frame
72 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Giorgi, MD
Phone
+393208588471
Email
antonio.giorgi@ospdaleniguarda.it
Facility Information:
Facility Name
ASST GOM Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures
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