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

NCT05105399 | Not Yet Recruiting

• 1 other identifier: SAP Versione 2 del 05/06/2020
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Rib Fractures; Spirometry

Outcome Measures

Primary Outcomes (1)

• 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

  72 hours

Study Arms (3)

Morphine

NO INTERVENTION

Continuous

ACTIVE COMPARATOR

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

Single

ACTIVE COMPARATOR

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

Interventions

Serratus plane block (continuous or single-shot) PROCEDURE

Patients assigned to the interventional arms will receive either continuous serratus plane block or single-shot serratus plane block

Continuous; Single

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST GOM Niguarda

Milan, 20162, Italy

Location

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Central Study Contacts

Antonio Giorgi, MD

CONTACT

+393208588471; antonio.giorgi@ospdaleniguarda.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 3, 2021
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

IT (1)