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Serratus Plane Block for Rib Fractures

Primary Purpose

Chest Trauma, Chest Pain

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Serratus plane block
Sponsored by
Arcispedale Santa Maria Nuova-IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Trauma

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • AUSL IRCCS Reggio EmiliaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

continuous

single-shot

Arm 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.

Single-shot serratus plane block with ropivacaine 0.37% solution 20 ml

Outcomes

Primary Outcome Measures

Pulmonary change function
FEV 1

Secondary Outcome Measures

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
Morphine
morphine requirement
hospital stay
time to fill the discharge criteria

Full Information

First Posted
September 2, 2018
Last Updated
May 7, 2019
Sponsor
Arcispedale Santa Maria Nuova-IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT03664973
Brief Title
Serratus Plane Block for Rib Fractures
Official Title
Effect of the Serratus Plane Block on the Outcome in Patient With Multiple Rib Fractures: A Prospective, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
October 3, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcispedale Santa Maria Nuova-IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Trauma, Chest Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
continuous
Arm Type
Experimental
Arm 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.
Arm Title
single-shot
Arm Type
Active Comparator
Arm Description
Single-shot serratus plane block with ropivacaine 0.37% solution 20 ml
Intervention Type
Procedure
Intervention Name(s)
Serratus plane block
Intervention Description
Local anesthetic infusion though a peripheral nerve catheter placed on the 5th rib under the serratus plane
Primary Outcome Measure Information:
Title
Pulmonary change function
Description
FEV 1
Time Frame
day 0 and day 3
Secondary Outcome Measure Information:
Title
Numerical rating scale (NRS) of pain
Description
Pain both at rest and on movement on a 0-10 scale where 0 is the best and 10 the worst
Time Frame
day 0, day 1, day 2, day 3, day 4
Title
Morphine
Description
morphine requirement
Time Frame
day 0, day 1, day 2, day 3, day 4
Title
hospital stay
Description
time to fill the discharge criteria
Time Frame
day 1, day 2, day 3, day 4, day 5, day 6, day7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
gianluca cappelleri
Phone
+390522296386
Email
gianluca.cappelleri@ausl.re.it
First Name & Middle Initial & Last Name or Official Title & Degree
gianluca cappelleri
Email
gianluca.cappelleri@ausl.re.it
Facility Information:
Facility Name
AUSL IRCCS Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42120
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
gianluca cappelleri, MD
Email
gianluca.cappelleri@ausl.re.it
First Name & Middle Initial & Last Name & Degree
gianluca cappelleri, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Serratus Plane Block for Rib Fractures

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