Mid-point to Pleura Transverse Process Block Versus Thoracic Intervertebral Foramen Block

Mid-point to Pleura Transverse Process Continuous Block Versus Thoracic Intervertebral Foramen Continuous Block, for Analgesia in Polytraumatic Patients With Multiple Rib Fractures

The analgesic effect of continuous mid-point to pleura transverse process block compared to the analgesic effect of continuous thoracic intervertebral foramen block, in patients with multiple rib fractures.

Study Overview

• Status: Recruiting
• Conditions: Pain, Acute; Rib Fractures; Polytrauma
• Intervention / Treatment: Procedure: Mid-point to pleura transverse process block; Procedure: Thoracic intervertebral foramen block

Detailed Description

The analgesic effect of continuous mid-point to pleura transverse process block will be compared to the analgesic effect of continuous thoracic intervertebral foramen block, in patients with multiple rib fractures, by using the numeric rating scale (NRS) for pain.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emiliano Petrucci, MD; Phone Number: +3908623681; Email: petrucciemiliano@gmail.com
• Study Contact Backup: Name: Franco Marinangeli, PhD, MD; Phone Number: +3908623681; Email: francomarinangeli@gmail.com

Study Locations

• Italy
  • L'Aquila, Italy, 67100
    • Recruiting
    • Emiliano
    • Contact: Emiliano Petrucci, MD; Phone Number: +3908623681; Email: petrucciemiliano@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoracic intervertebral foramen block; Under ultrasound guidance the continuous thoracic intervertebral foramen 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.	Procedure: Thoracic intervertebral foramen block; Under ultrasound guidance the continuous thoracic intervertebral foramen 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.
Active Comparator: Mid-point to pleura transverse process block; 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.	Procedure: Mid-point to pleura transverse process block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	First 72 hours from the block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragmatic motion	The percentage of diaphragmatic thickening measured as thickness at end-inspiration-thickness at end-expiration divided by thickness at end-expiration	First 72 hours from the block
Arterial blood gas analysis	Fraction of inspired oxygen to partial pressure of oxygen ratio	First 72 hours from the block
Airflow rate	Patient airflow rate measured in mL/second, by using an incentive spirometer with three balls	First 72 hours from the block
Blood pressure	Invasive blood pressure (systolic and diastolic pressure in mmHg)	First 72 hours from the block
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.	First 72 hours from the block
Request of analgesic drugs	Consumption of analgesic drugs (equivalent mg of morphine)	First 72 hours from the block
Anesthetic spread	Thoracic paravertebral space spread (yes or no), evaluated with ultrasonography	First 72 hours from the block
Complication	Number of pneumothorax, hemothorax, hematoma, pain, infection, and neurological impairment by the block	First 72 hours from the block

Collaborators and Investigators

• Sponsor: San Salvatore Hospital of L'Aquila
• Investigators: Principal Investigator: Emiliano Petrucci, MD, San Salvatore Acadec Hospital of L'Aquila (Italy)

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): April 4, 2024

Study Registration Dates

• First Submitted: April 2, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Analgesia; Ultrasound guidance; Local anesthetics; Myofascial block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Acute Pain; Multiple Trauma; Rib Fractures
• Other Study ID Numbers: 10814/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No