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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05348330
Other study ID # 10814/21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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