Serratus Plane Block for Rib Fractures

Chest Pain Clinical Trial

Official title:

Effect of the Serratus Plane Block on the Outcome in Patient With Multiple Rib Fractures: A Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03664973
• Other study ID #: Serratus GC
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: October 3, 2019

Study information

• Verified date: May 2019
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: gianluca cappelleri
• Phone: +390522296386
• Email: gianluca.cappelleri[@]ausl.re.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 3, 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain
• Chest Trauma
• Rib Fractures
• Thoracic Injuries

Intervention

Procedure:
• Serratus plane block
Local anesthetic infusion though a peripheral nerve catheter placed on the 5th rib under the serratus plane

Locations

Country	Name	City	State
Italy	AUSL IRCCS Reggio Emilia	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary change function	FEV 1	day 0 and day 3
Secondary	Numerical rating scale (NRS) of pain	Pain both at rest and on movement on a 0-10 scale where 0 is the best and 10 the worst	day 0, day 1, day 2, day 3, day 4
Secondary	Morphine	morphine requirement	day 0, day 1, day 2, day 3, day 4
Secondary	hospital stay	time to fill the discharge criteria	day 1, day 2, day 3, day 4, day 5, day 6, day7