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

Not Applicable
Completed
Conditions
Pain, Acute
Rib Fractures
Polytrauma
Interventions
Procedure: Thoracic intervertebral foramen block
Procedure: Mid-point to pleura transverse process block
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.

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
Arm && Interventions
GroupInterventionDescription
Thoracic intervertebral foramen blockThoracic intervertebral foramen blockUnder 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.
Mid-point to pleura transverse process blockMid-point to pleura transverse process blockUnder 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.
Primary Outcome Measures
NameTimeMethod
Pain intensityFirst 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
NameTimeMethod
Sensory blockFirst 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.

Blood pressureFirst 72 hours from the block

Invasive blood pressure (systolic and diastolic pressure in mmHg)

Request of analgesic drugsFirst 72 hours from the block

Consumption of analgesic drugs (equivalent mg of morphine)

Anesthetic spreadFirst 72 hours from the block

Thoracic paravertebral space spread (yes or no), evaluated with ultrasonography

ComplicationFirst 72 hours from the block

Number of pneumothorax, hemothorax, hematoma, pain, infection, and neurological impairment by the block

Arterial blood gas analysisFirst 72 hours from the block

Fraction of inspired oxygen to partial pressure of oxygen ratio

Airflow rateFirst 72 hours from the block

Patient airflow rate measured in mL/second, by using an incentive spirometer with three balls

Diaphragmatic motionFirst 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

Trial Locations

Locations (1)

Emiliano

🇮🇹

L'Aquila, Italy

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