Serratus Plane Block for Rib Fractures

NCT ID: NCT03664973

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2023-12-30

Brief Summary

Patients with ipsilateral multiple rib fractures will be randomized to receive either a single-shot ultrasound-guided serratus plane block, or a continuous serratus plane block within 24h from the chest trauma. Primary outcome is the difference in forced respiratory volume (FEV1) at 72h.

Detailed Description

Patients admitted in emergency department with a chest trauma and ipsilateral multiple rib fractures, will be randomized as described above. All patients will receive the serratus block with a ropivacaine 0.37% solution 20 ml. Then, they will randomized to receive either a peripheral catheter placed above the 5th rib on the middle axillary line, or nothing. In all patients postoperative analgesia also include Paracetamol 1g IV each 6h and a patient controlled analgesia (PCA) of morphine set out as follow: bolus 1 mg, loch out 15 min, max 4 boluses each hour. In all patients an arterial blood sample for gas analysis and a FEV1 will be achieved before the block, after 1 hour and at 72h.

Conditions

Chest Trauma; Chest Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

continuous

continuous local anesthetic infusion (ropivacaine 0.2%)on the serratus plane for at least 72h adds to a Single-shot serratus plane block with ropivacaine 0.37% solution 20 ml.

Group Type: EXPERIMENTAL

Serratus plane block

Intervention Type: PROCEDURE

Local anesthetic infusion though a peripheral nerve catheter placed on the 5th rib under the serratus plane

single-shot

Single-shot serratus plane block with ropivacaine 0.37% solution 20 ml

Group Type: ACTIVE_COMPARATOR

Serratus plane block

Intervention Type: PROCEDURE

Local anesthetic infusion though a peripheral nerve catheter placed on the 5th rib under the serratus plane

Interventions

Serratus plane block

Local anesthetic infusion though a peripheral nerve catheter placed on the 5th rib under the serratus plane

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 2 o more ipsilateral rib fractures
• Trauma within 24h from hospital admission
• Informed consent

Exclusion Criteria

• Chest drain
• head trauma
• bilateral rib fractures
• Intensive care admission

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AUSL IRCCS Reggio Emilia

Reggio Emilia, , Italy

Countries

Italy

Other Identifiers

Serratus GC

Identifier Type: -

Identifier Source: org_study_id