Rib FracturesNCT06981728
Ultrasound-Guided Mid-Point Transverse Process to Pleura Block Versus Thoracic Paravertebral Block for Pain Management in Patients With Multiple Rib Fractures (A Prospective Randomized Double- Blinded, Non-inferiority Trial )
A study testing Mid point transverse to pleura block in people with Rib Fractures, run by Assiut University.
Trial summary
The aim of our study is to investigate whether the analgesic effect of MTPB is non inferior to that of TPVB in trauma patients with multiple rib fractures. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rib Fractures
- What is being tested?
- Mid point transverse to pleura block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients aged between 18 and 70 years, from both genders, who had uni lateral traumatic multiple rib fractures (three or more confirmed by a CT chest scan).
Who cannot join
- Significant head injury/unconsciousness (GCS less than 15).
- Patients with Pain score >6.
- those having significant trauma outside the chest wall, e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries.
- Obese patients with body mass index ≥ 35.
- coagulopathy.
- History of drug allergy to local anesthetics.
Show all 9Show fewer
- Patient refusal.
- Local infection at the injection site.
- Opioid addiction.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of our study is to investigate whether the analgesic effect of MTPB is non inferior to that of TPVB in trauma patients with multiple rib fractures.
Read the detailed description
Trauma is a major global health problem. In Egypt, trauma-related death accounted for 8% of total fatalities and was the eighth leading cause of death in 2010. However.[1]Rib fractures have an incidence around 10% of all trauma patients and over 30% of chest trauma patients.[2] Multiple fractured ribs are associated with extreme pain, to avoid intensifying discomfort, patients' breathing becomes shallower and they repress coughing, leading to respiratory insufficiency. Which may result in numerous complications, as sputum retention, atelectasis, infection, and respiratory insufficiency. This is associated with increase in intensive care admissions and mortality (25%).[3] Hence, pain control is the cornerstone of rib fracture management. Modalities for pain relief ranges from oral administration of analgesic drugs to regional nerve blocks including [intrapleural, intercostal ,thoracic paravertebral nerve blockade (TPVB)]. Despite the low rate of technical failure in TPVB execution (6.1%), pulmonary complications, such as inadvertent pleural puncture (0.8%) and pneumothorax (0.5%), are still a recognized risk.[4] Bedside ED-performed ultrasound-guided anesthesia is gaining in popularity, and early and adequate pain control has shown improved patient outcomes with rare complications.
One of the most recently described technique is mid-point transverse process to pleura (MTP) block.[2] In MTP block, the local anesthetic drug is deposited at the mid-point between the transverse process and pleura and it reaches the paravertebral space by diffusion. With this technique, even if superior costotransverse ligament (SCTL) is not visible, effective block can be achieved. In addition, needle is placed far away from pleura minimizing the rate of pneumothorax.[5]
- Conditions
- Rib Fractures
- Being tested
- Mid point transverse to pleura block
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid point transverse to pleura blockProcedure or surgery
Also called Thoracic paravertebral block
TPVB and MTPB was performed at a spinal level midway between the uppermost and the lowest fractured rib, with the patient in a sitting position, and under complete aseptic conditions, a linear ultrasound probe (GE Healthcare-Logiq F6) will be placed oblique parasagittally 3 cm lateral to spinous process used to identify the transverse process, pleura, superior costotransverse ligament, and the paravertebral space at the target vertebral level.
After skin and subcutaneous tissue infiltration with 2-3 mL of 2% lignocaine, an 18-gauge Touhy needle was inserted under ultrasound guidance until the needle tip reaches :
- the midpoint between the transverse process and the pleura (group M).
- the paravertebral space (group P). A bolus dose (0.3mL/kg) of plain bupivacaine 0.5% plus 8 mg of dexamethasone was injected after negative aspiration to blood and air.
| Study group | Role | What they receive |
|---|---|---|
| M (MTPB) | Active comparator | Mid-point transverse to pleura block Receives: Procedure: Mid point transverse to pleura block |
| P (TPVB) | Sham comparator | Thoracic paravertebral block Receives: Procedure: Mid point transverse to pleura block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the mean difference in numeric rating pain scores (NRS) between the MTPB and TPVB groups at 24-hour after the block.
Measured: 24hour
Secondary outcomes (8)
• NRS scores at different times up to 24 hours.
Measured: 72hour
Time for first analgesic request. • Total 24 hours analgesic consumption.
Measured: 24hour
• Total 24 hours analgesic consumption.
Measured: 24hour
• Time for block performance.
Measured: 30min
• Dermatomal block effect.
Measured: 24hour
inspiratory volumes (mL) measured with a volume incentive spirometer.
Measured: 72hour
respiratory rate (RR),Heart rate (HR), Blood Pressure (BP), peripheral oxygen saturation (SpO2),and need for mechanical ventilation.
Measured: 3 days
• Complications such as pneumothorax bradycardia hypotension. • development of pneumonia, hospital length of stay, and mortality.
Measured: 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Yassien Mahmoud Ahmed, Assiut University
- Investigators
- alaa attia, professor, Study director, alaaguhina@aun.edu.egMonira Ismail, professor, Study director, Monira.taha77@med.suez.edu.egmuhamed mamdouh, lecturer, Study director, mamdouh372@med.aun.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981728
- Sponsor's protocol ID
- fracture ribs
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Mid-Point Transverse Process to Pleura Block Versus Thoracic Paravertebral Block for Pain Management in Patients With Multiple Rib Fractures (A Prospective Randomized Double- Blinded, Non-inferiority Trial )
- ClinicalTrials.gov ID
- NCT06981728
- Acronym / sponsor ID
- fracture ribs
- Conditions
- Rib Fractures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 21 May 2025 (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 aim of our study is to investigate whether the analgesic effect of MTPB is non inferior to that of TPVB in trauma patients with multiple rib fractures.
Detailed description
Trauma is a major global health problem. In Egypt, trauma-related death accounted for 8% of total fatalities and was the eighth leading cause of death in 2010. However.[1]Rib fractures have an incidence around 10% of all trauma patients and over 30% of chest trauma patients.[2] Multiple fractured ribs are associated with extreme pain, to avoid intensifying discomfort, patients' breathing becomes shallower and they repress coughing, leading to respiratory insufficiency. Which may result in numerous complications, as sputum retention, atelectasis, infection, and respiratory insufficiency. This is associated with increase in intensive care admissions and mortality (25%).[3] Hence, pain control is the cornerstone of rib fracture management. Modalities for pain relief ranges from oral administration of analgesic drugs to regional nerve blocks including [intrapleural, intercostal ,thoracic paravertebral nerve blockade (TPVB)]. Despite the low rate of technical failure in TPVB execution (6.1%), pulmonary complications, such as inadvertent pleural puncture (0.8%) and pneumothorax (0.5%), are still a recognized risk.[4] Bedside ED-performed ultrasound-guided anesthesia is gaining in popularity, and early and adequate pain control has shown improved patient outcomes with rare complications.
One of the most recently described technique is mid-point transverse process to pleura (MTP) block.[2] In MTP block, the local anesthetic drug is deposited at the mid-point between the transverse process and pleura and it reaches the paravertebral space by diffusion. With this technique, even if superior costotransverse ligament (SCTL) is not visible, effective block can be achieved. In addition, needle is placed far away from pleura minimizing the rate of pneumothorax.[5]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M (MTPB) | Active comparator | Procedure: Mid point transverse to pleura blockMid-point transverse to pleura block |
| P (TPVB) | Sham comparator | Procedure: Mid point transverse to pleura blockThoracic paravertebral block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged between 18 and 70 years, from both genders, who had uni lateral traumatic multiple rib fractures (three or more confirmed by a CT chest scan).
Key exclusion criteria (9 listed)
- Significant head injury/unconsciousness (GCS less than 15).
- Patients with Pain score >6.
- those having significant trauma outside the chest wall, e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries.
- Obese patients with body mass index ≥ 35.
- coagulopathy.
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 |
|---|---|---|
| Mid point transverse to pleura blockAlso: Thoracic paravertebral blockTPVB and MTPB was performed at a spinal level midway between the uppermost and the lowest fractured rib, with the patient in a sitting position, and under complete aseptic conditions, a linear ultrasound probe (GE Healthcare-Logiq F6) will be placed oblique parasagittally 3 cm lateral to spinous process used to identify the transverse process, pleura, superior costotransverse ligament, and the paravertebral space at the target vertebral level. After skin and subcutaneous tissue infiltration with 2-3 mL of 2% lignocaine, an 18-gauge Touhy needle was inserted under ultrasound guidance until the needle tip reaches : * the midpoint between the transverse process and the pleura (group M). * the paravertebral space (group P). A bolus dose (0.3mL/kg) of plain bupivacaine 0.5% plus 8 mg of dexamethasone was injected after negative aspiration to blood and air. | Procedure or surgery | M (MTPB), P (TPVB) |
Primary outcome
The primary outcome will be the mean difference in numeric rating pain scores (NRS) between the MTPB and TPVB groups at 24-hour after the block.
Time frame: 24hour
8 secondary outcomes
• NRS scores at different times up to 24 hours.
Time frame: 72hour
Time for first analgesic request. • Total 24 hours analgesic consumption.
Time frame: 24hour
• Total 24 hours analgesic consumption.
Time frame: 24hour
• Time for block performance.
Time frame: 30min
• Dermatomal block effect.
Time frame: 24hour
inspiratory volumes (mL) measured with a volume incentive spirometer.
Time frame: 72hour
respiratory rate (RR),Heart rate (HR), Blood Pressure (BP), peripheral oxygen saturation (SpO2),and need for mechanical ventilation.
Time frame: 3 days
• Complications such as pneumothorax bradycardia hypotension. • development of pneumonia, hospital length of stay, and mortality.
Time frame: 3days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Rib Fractures
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INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
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Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
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Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
Not yet recruitingPhase 2/3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Rib Fractures, Acute Pain
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
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.
alaa attia, professor study director
alaaguhina@aun.edu.eg
Monira Ismail, professor study director
Monira.taha77@med.suez.edu.eg
muhamed mamdouh, lecturer study director
mamdouh372@med.aun.edu.eg
Questions about this trial
What is this clinical trial studying?
A study testing Mid point transverse to pleura block in people with Rib Fractures, run by Assiut University.
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 9 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: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact aya yassien, MD (01096577262, aya.yassien1994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be the mean difference in numeric rating pain scores (NRS) between the MTPB and TPVB groups at 24-hour after the block. (time frame: 24hour). 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 21 May 2025.