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

Not Applicable

Completed

• Conditions: Pain, Acute; Rib Fractures; Polytrauma

• Registration Number: NCT05348330
• Lead Sponsor: San Salvatore Hospital of L'Aquila

Brief 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.

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 Timeline

• Study First Submitted: 2022-04-02
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-27
• Study Start: 2022-12-04
• Primary Completion: 2024-10-31
• Status Verified: 2024-11
• Study Completion: 2024-11-28
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity	First 72 hours from the block	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

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

Trial Locations

Locations (1)

Emiliano; 🇮🇹 L'Aquila, Italy