Serratus Plane Block for Rib Fractures

Not Applicable

Withdrawn

• Conditions: Chest Trauma; Chest Pain

• Registration Number: NCT03664973
• Lead Sponsor: Azienda USL Reggio Emilia - IRCCS

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.

Study Timeline

• Study First Submitted: 2018-09-02
• Study Start: 2018-09-03
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Status Verified: 2019-05
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pulmonary change function	day 0 and day 3	FEV 1

Secondary Outcome Measures

Name	Time	Method
Morphine	day 0, day 1, day 2, day 3, day 4	morphine requirement
Numerical rating scale (NRS) of pain	day 0, day 1, day 2, day 3, day 4	Pain both at rest and on movement on a 0-10 scale where 0 is the best and 10 the worst
hospital stay	day 1, day 2, day 3, day 4, day 5, day 6, day7	time to fill the discharge criteria

Trial Locations

Locations (1)

AUSL IRCCS Reggio Emilia; 🇮🇹 Reggio Emilia, Italy