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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03664973
Other study ID # Serratus GC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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