Back to resultsMid-point to Pleura Transverse Process Block Versus Costo-transverse Ligament Block
Primary Purpose
Pain, Acute, Rib Fractures, Polytrauma
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mid-point to pleura transverse process block
Costo-transverse ligament block,
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute focused on measuring Analgesia, Local anesthetics, Myofascial block, Ultrasound guidance
Eligibility Criteria
Inclusion Criteria:
- ribs fracture after polytrauma
Exclusion Criteria:
- pregnancy
- allergy to anesthetics
- head trauma
- history of neurological impairment (primary or secondary)
- history of cancer
- history of chronic obstructive pulmonary disease
- infections of skin close to the block site
- systemic infections
Sites / Locations
- EmilianoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mid-point to pleura transverse process block
Costo-transverse ligament block
Arm Description
Under ultrasound guidance the continuous mid-point to pleura transverse process block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain.
Under ultrasound guidance the continuous costo-transverse ligament block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain.
Outcomes
Primary Outcome Measures
Pain intensity
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"
Secondary Outcome Measures
Diaphragmatic motion
The percentage of diaphragmatic thickening measured as thickness at end-inspiration-thickness at end-expiration divided by thickness at end-expiration
Arterial blood gas analysis
Fraction of inspired oxygen to partial pressure of oxygen ratio
Airflow rate
Patient airflow rate measured in mL/second, by using an incentive spirometer with three balls
Blood pressure
Invasive blood pressure (systolic and diastolic pressure in mmHg)
Sensory block
Response to the stimulus (yes or no), by using a piece of cotton, and ice in a finger of surgical glove on the patient's skin.
Request of analgesic drugs
Consumption of analgesic drugs (equivalent mg of morphine)
Anesthetic spread
Thoracic paravertebral space spread (yes or no), evaluated with ultrasonography
Complication
Number of pneumothorax, hemothorax, hematoma, pain, infection, and neurological impairment by the block
Full Information
NCT ID
NCT05348330
First Posted
April 2, 2022
Last Updated
June 13, 2023
Sponsor
San Salvatore Hospital of L'Aquila
1. Study Identification
Unique Protocol Identification Number
NCT05348330
Brief Title
Mid-point to Pleura Transverse Process Block Versus Costo-transverse Ligament Block
Official Title
Mid-point to Pleura Transverse Process Continuous Block Versus Costo-transverse Ligament Continuous Block, for Analgesia in Polytraumatic Patients With Multiple Rib Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2022 (Actual)
Primary Completion Date
August 4, 2023 (Anticipated)
Study Completion Date
April 4, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Salvatore Hospital of L'Aquila
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The analgesic effect of continuous mid-point to pleura transverse process block compared to the analgesic effect of continuous costo-transverse ligament block, in patients with multiple rib fractures.
Detailed Description
The analgesic effect of continuous mid-point to pleura transverse process block will be compared to the analgesic effect of continuous costo-transverse ligament block, in patients with multiple rib fractures, by using the numeric rating scale (NRS) for pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Rib Fractures, Polytrauma
Keywords
Analgesia, Local anesthetics, Myofascial block, Ultrasound guidance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mid-point to pleura transverse process block
Arm Type
Experimental
Arm Description
Under ultrasound guidance the continuous mid-point to pleura transverse process block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain.
Arm Title
Costo-transverse ligament block
Arm Type
Active Comparator
Arm Description
Under ultrasound guidance the continuous costo-transverse ligament block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain.
Intervention Type
Procedure
Intervention Name(s)
Mid-point to pleura transverse process block
Intervention Description
Under ultrasound guidance the continuous mid-point to pleura transverse process block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain. The block will be performed close, by considering the level of rib fractures.
Intervention Type
Procedure
Intervention Name(s)
Costo-transverse ligament block,
Intervention Description
Under ultrasound guidance the continuous costo-transverse ligament block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain. The block will be performed close, by considering the level of rib fractures.
Primary Outcome Measure Information:
Title
Pain intensity
Description
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"
Time Frame
First 72 hours from the block
Secondary Outcome Measure Information:
Title
Diaphragmatic motion
Description
The percentage of diaphragmatic thickening measured as thickness at end-inspiration-thickness at end-expiration divided by thickness at end-expiration
Time Frame
First 72 hours from the block
Title
Arterial blood gas analysis
Description
Fraction of inspired oxygen to partial pressure of oxygen ratio
Time Frame
First 72 hours from the block
Title
Airflow rate
Description
Patient airflow rate measured in mL/second, by using an incentive spirometer with three balls
Time Frame
First 72 hours from the block
Title
Blood pressure
Description
Invasive blood pressure (systolic and diastolic pressure in mmHg)
Time Frame
First 72 hours from the block
Title
Sensory block
Description
Response to the stimulus (yes or no), by using a piece of cotton, and ice in a finger of surgical glove on the patient's skin.
Time Frame
First 72 hours from the block
Title
Request of analgesic drugs
Description
Consumption of analgesic drugs (equivalent mg of morphine)
Time Frame
First 72 hours from the block
Title
Anesthetic spread
Description
Thoracic paravertebral space spread (yes or no), evaluated with ultrasonography
Time Frame
First 72 hours from the block
Title
Complication
Description
Number of pneumothorax, hemothorax, hematoma, pain, infection, and neurological impairment by the block
Time Frame
First 72 hours from the block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ribs fracture after polytrauma
Exclusion Criteria:
pregnancy
allergy to anesthetics
head trauma
history of neurological impairment (primary or secondary)
history of cancer
history of chronic obstructive pulmonary disease
infections of skin close to the block site
systemic infections
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emiliano Petrucci, MD
Phone
+3908623681
Email
petrucciemiliano@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Franco Marinangeli, PhD, MD
Phone
+3908623681
Email
francomarinangeli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emiliano Petrucci, MD
Organizational Affiliation
San Salvatore Acadec Hospital of L'Aquila (Italy)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emiliano
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emiliano Petrucci, MD
Phone
+3908623681
Email
petrucciemiliano@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Mid-point to Pleura Transverse Process Block Versus Costo-transverse Ligament Block
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