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NCT Number: NCT05348330

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

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.

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Key information

Conditions

Pain, Acute Acute Pain Agnosia Fractures, Bone Multiple Trauma Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Polytrauma Rib Fractures Signs and Symptoms Thoracic Injuries Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emiliano

L’Aquila, L'Aquila, 67100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracic intervertebral foramen block

Procedure

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

Procedure

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.

Primary outcomes

  1. Pain intensity

    Time frame: 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 outcomes

  1. Diaphragmatic motion

    Time frame: 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

  2. Arterial blood gas analysis

    Time frame: First 72 hours from the block

    Fraction of inspired oxygen to partial pressure of oxygen ratio

  3. Airflow rate

    Time frame: First 72 hours from the block

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

  4. Blood pressure

    Time frame: First 72 hours from the block

    Invasive blood pressure (systolic and diastolic pressure in mmHg)

  5. Sensory block

    Time frame: 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.

  6. Request of analgesic drugs

    Time frame: First 72 hours from the block

    Consumption of analgesic drugs (equivalent mg of morphine)

  7. Anesthetic spread

    Time frame: First 72 hours from the block

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

  8. Complication

    Time frame: First 72 hours from the block

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

Sponsors and collaborators

Lead sponsor

San Salvatore Hospital of L'Aquila

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2022
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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