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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05348330
• Other study ID #: 10814/21
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2022
• Est. completion date: April 4, 2024

Study information

• Verified date: March 2024
• Source: San Salvatore Hospital of L'Aquila
• Contact: Emiliano Petrucci, MD
• Phone: +3908623681
• Email: petrucciemiliano[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 4, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Multiple Trauma
• Pain, Acute
• Polytrauma
• Rib Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Emiliano	L'Aquila

Sponsors (1)

Lead Sponsor	Collaborator
San Salvatore Hospital of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Arterial blood gas analysis	Fraction of inspired oxygen to partial pressure of oxygen ratio	First 72 hours from the block
Secondary	Airflow rate	Patient airflow rate measured in mL/second, by using an incentive spirometer with three balls	First 72 hours from the block
Secondary	Blood pressure	Invasive blood pressure (systolic and diastolic pressure in mmHg)	First 72 hours from the block
Secondary	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
Secondary	Request of analgesic drugs	Consumption of analgesic drugs (equivalent mg of morphine)	First 72 hours from the block
Secondary	Anesthetic spread	Thoracic paravertebral space spread (yes or no), evaluated with ultrasonography	First 72 hours from the block
Secondary	Complication	Number of pneumothorax, hemothorax, hematoma, pain, infection, and neurological impairment by the block	First 72 hours from the block