Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Serratus Plane Block for Rib Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03664973
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Arcispedale Santa Maria Nuova-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.

Condition or disease Intervention/treatment Phase
Chest Trauma Chest Pain Procedure: Serratus plane block Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of the Serratus Plane Block on the Outcome in Patient With Multiple Rib Fractures: A Prospective, Randomized, Controlled Trial
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 3, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: Serratus plane block
Local anesthetic infusion though a peripheral nerve catheter placed on the 5th rib under the serratus plane

Active Comparator: single-shot
Single-shot serratus plane block with ropivacaine 0.37% solution 20 ml
Procedure: Serratus plane block
Local anesthetic infusion though a peripheral nerve catheter placed on the 5th rib under the serratus plane




Primary Outcome Measures :
  1. Pulmonary change function [ Time Frame: day 0 and day 3 ]
    FEV 1


Secondary Outcome Measures :
  1. Numerical rating scale (NRS) of pain [ Time Frame: 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

  2. Morphine [ Time Frame: day 0, day 1, day 2, day 3, day 4 ]
    morphine requirement

  3. hospital stay [ Time Frame: day 1, day 2, day 3, day 4, day 5, day 6, day7 ]
    time to fill the discharge criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664973


Contacts
Layout table for location contacts
Contact: gianluca cappelleri +390522296386 gianluca.cappelleri@ausl.re.it
Contact: gianluca cappelleri gianluca.cappelleri@ausl.re.it

Locations
Layout table for location information
Italy
AUSL IRCCS Reggio Emilia Recruiting
Reggio Emilia, Italy, 42120
Contact: gianluca cappelleri, MD       gianluca.cappelleri@ausl.re.it   
Contact: gianluca cappelleri, MD         
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS

Layout table for additonal information
Responsible Party: Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT03664973     History of Changes
Other Study ID Numbers: Serratus GC
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Chest Pain
Rib Fractures
Thoracic Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Fractures, Bone
Wounds and Injuries