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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05348330
Enrollment
100
Registered
2022-04-27
Start date
2022-12-04
Completion date
2024-11-28
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Acute, Polytrauma, Rib Fractures

Keywords

Analgesia, Local anesthetics, Myofascial block, Ultrasound guidance

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.

Interventions

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.

PROCEDUREMid-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.

Sponsors

San Salvatore Hospital of L'Aquila
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensityFirst 72 hours from the blockThe 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

MeasureTime frameDescription
Arterial blood gas analysisFirst 72 hours from the blockFraction of inspired oxygen to partial pressure of oxygen ratio
Airflow rateFirst 72 hours from the blockPatient airflow rate measured in mL/second, by using an incentive spirometer with three balls
Blood pressureFirst 72 hours from the blockInvasive blood pressure (systolic and diastolic pressure in mmHg)
Diaphragmatic motionFirst 72 hours from the blockThe percentage of diaphragmatic thickening measured as thickness at end-inspiration-thickness at end-expiration divided by thickness at end-expiration
Request of analgesic drugsFirst 72 hours from the blockConsumption of analgesic drugs (equivalent mg of morphine)
Anesthetic spreadFirst 72 hours from the blockThoracic paravertebral space spread (yes or no), evaluated with ultrasonography
ComplicationFirst 72 hours from the blockNumber of pneumothorax, hemothorax, hematoma, pain, infection, and neurological impairment by the block
Sensory blockFirst 72 hours from the blockResponse 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026