Pain, AcuteNCT05348330
Mid-point to Pleura Transverse Process Block Versus Thoracic Intervertebral Foramen Block
A study testing Thoracic intervertebral foramen block and Mid-point to pleura transverse process block in people with Pain, Acute and Rib Fractures, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Acute, Rib Fractures, Polytrauma
- What is being tested?
- Thoracic intervertebral foramen block and Mid-point to pleura transverse process block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 4 Dec 2022to 28 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ribs fracture after polytrauma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mid-point to Pleura Transverse Process Continuous Block Versus Thoracic Intervertebral Foramen Continuous Block, for Analgesia in Polytraumatic Patients with Multiple Rib Fractures
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.
Read the 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.
- Conditions
- Pain, Acute, Rib Fractures, Polytrauma
- Being tested
- Thoracic intervertebral foramen block, Mid-point to pleura transverse process block
- Keywords
- Analgesia, Local anesthetics, Myofascial block, Ultrasound guidance
- Medical subject headings
- Acute Pain, Rib Fractures, Multiple Trauma, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic intervertebral foramen blockProcedure or surgery
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 blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic intervertebral foramen block | Experimental | 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. Receives: Procedure: Thoracic intervertebral foramen block |
| Mid-point to pleura transverse process block | Active comparator | 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. Receives: Procedure: Mid-point to pleura transverse process block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: First 72 hours from the block
Secondary outcomes (8)
Diaphragmatic motion
The percentage of diaphragmatic thickening measured as thickness at end-inspiration-thickness at end-expiration divided by thickness at end-expiration
Measured: First 72 hours from the block
Arterial blood gas analysis
Fraction of inspired oxygen to partial pressure of oxygen ratio
Measured: First 72 hours from the block
Airflow rate
Patient airflow rate measured in mL/second, by using an incentive spirometer with three balls
Measured: First 72 hours from the block
Blood pressure
Invasive blood pressure (systolic and diastolic pressure in mmHg)
Measured: 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.
Measured: First 72 hours from the block
Request of analgesic drugs
Consumption of analgesic drugs (equivalent mg of morphine)
Measured: First 72 hours from the block
Anesthetic spread
Thoracic paravertebral space spread (yes or no), evaluated with ultrasonography
Measured: First 72 hours from the block
Complication
Number of pneumothorax, hemothorax, hematoma, pain, infection, and neurological impairment by the block
Measured: First 72 hours from the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start4 Dec 2022
- Primary completion31 Oct 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Salvatore Hospital of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emiliano Petrucci, San Salvatore Hospital of L'Aquila
- Investigators
- Emiliano Petrucci, MD, Principal investigator, San Salvatore Acadec Hospital of L'Aquila (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348330
- Sponsor's protocol ID
- 10814/21
- Status last verified
- Nov 2024
- First submitted
- 2 Apr 2022
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-point to Pleura Transverse Process Continuous Block Versus Thoracic Intervertebral Foramen Continuous Block, for Analgesia in Polytraumatic Patients with Multiple Rib Fractures
- ClinicalTrials.gov ID
- NCT05348330
- Acronym / sponsor ID
- 10814/21
- Conditions
- Pain, Acute, Rib Fractures, Polytrauma
- Keywords
- Analgesia, Local anesthetics, Myofascial block, Ultrasound guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- San Salvatore Hospital of L'AquilaUniversity, hospital or other
- Study start
- 4 Dec 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic intervertebral foramen block | Experimental | Procedure: Thoracic 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 block | Active comparator | Procedure: Mid-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ribs fracture after polytrauma
Key exclusion criteria (8 listed)
- pregnancy
- allergy to anesthetics
- head trauma
- history of neurological impairment (primary or secondary)
- history of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic 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. The block will be performed close, by considering the level of rib fractures. | Procedure or surgery | Thoracic intervertebral foramen block |
| Mid-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. The block will be performed close, by considering the level of rib fractures. | Procedure or surgery | Mid-point to pleura transverse process block |
Primary outcome
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"
8 secondary outcomes
Diaphragmatic motion
Time frame: First 72 hours from the block
Arterial blood gas analysis
Time frame: First 72 hours from the block
Airflow rate
Time frame: First 72 hours from the block
Blood pressure
Time frame: First 72 hours from the block
Sensory block
Time frame: First 72 hours from the block
Request of analgesic drugs
Time frame: First 72 hours from the block
Anesthetic spread
Time frame: First 72 hours from the block
Complication
Time frame: First 72 hours from the block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emiliano Petrucci, MD principal investigator
San Salvatore Acadec Hospital of L'Aquila (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic intervertebral foramen block and Mid-point to pleura transverse process block in people with Pain, Acute and Rib Fractures, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: First 72 hours from the block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.