An interventional study of Thoracic intervertebral foramen block and Mid-point to pleura transverse process block in Pain, Acute, Rib Fractures and Polytrauma, sponsored by San Salvatore Hospital of L'Aquila. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by San Salvatore Hospital of L'Aquila · Not applicable, Interventional, and Treatment
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.
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.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's enrollment of 100 is above the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →San Salvatore Hospital of L'Aquila is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Thoracic intervertebral foramen 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.
Procedure: Mid-point to pleura transverse process 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.
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.
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"
Time frame: First 72 hours from the block
Diaphragmatic motion
The percentage of diaphragmatic thickening measured as thickness at end-inspiration-thickness at end-expiration divided by thickness at end-expiration
Time frame: First 72 hours from the block
Arterial blood gas analysis
Fraction of inspired oxygen to partial pressure of oxygen ratio
Time frame: First 72 hours from the block
Airflow rate
Patient airflow rate measured in mL/second, by using an incentive spirometer with three balls
Time frame: First 72 hours from the block
Blood pressure
Invasive blood pressure (systolic and diastolic pressure in mmHg)
Time frame: First 72 hours from the block
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.
Time frame: First 72 hours from the block
Request of analgesic drugs
Consumption of analgesic drugs (equivalent mg of morphine)
Time frame: First 72 hours from the block
Anesthetic spread
Thoracic paravertebral space spread (yes or no), evaluated with ultrasonography
Time frame: First 72 hours from the block
Complication
Number of pneumothorax, hemothorax, hematoma, pain, infection, and neurological impairment by the block
Time frame: First 72 hours from the block
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2022 to primary completion in Oct 2024, 22 months.
Of 424 non-industry interventional studies with no phase under Acute Pain, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's 22 months is above that.
Counting every sponsor, half of 430 studies reached it within 11 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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San Salvatore Hospital of L'Aquila