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Serratus Plane Block for Rib Fractures

A

Azienda USL Reggio Emilia - IRCCS

Status

Withdrawn

Conditions

Chest Trauma
Chest Pain

Treatments

Procedure: Serratus plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT03664973
Serratus GC

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

continuous
Experimental group
Description:
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.
Treatment:
Procedure: Serratus plane block
single-shot
Active Comparator group
Description:
Single-shot serratus plane block with ropivacaine 0.37% solution 20 ml
Treatment:
Procedure: Serratus plane block

Trial contacts and locations

1

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Central trial contact

gianluca cappelleri; gianluca cappelleri

Data sourced from clinicaltrials.gov

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