Multiple Rib FracturesPhase 4NCT06958549
Role of Nerve Block in Management of Multiple Rib Fractures
A Phase 4 study testing Nerve block with Lidocain and pharmacological analgesics in people with Multiple Rib Fractures, run by Assiut University.
Trial summary
Epidemiology \& Impact Thoracic trauma is a common and serious injury worldwide-especially in developing countries-and carries high rates of morbidity and mortality. Complications arise primarily from hypoventilation, which leads to atelectasis, pneumonia, and respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Rib Fractures
- What is being tested?
- Nerve block with Lidocain and pharmacological analgesics
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Apr 2027
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All trauma adult patient (18-70 years) with multiple fracture ribs
Who cannot join
- Patient with multiple fracture rib with anterior flail segment
- Significant head trauma
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
Official title: Management of Multiple Rib Fractures; Role of Nerve Block
- Epidemiology \& Impact Thoracic trauma is a common and serious injury worldwide-especially in developing countries-and carries high rates of morbidity and mortality. Complications arise primarily from hypoventilation, which leads to atelectasis, pneumonia, and respiratory failure.
- Key to Reducing Complications: Pain Control Effective analgesia is the cornerstone of preventing respiratory complications. Inadequate pain relief causes patients to splint and hypoventilate, setting the stage for pulmonary collapse and infection.
- Conservative Management
- Analgesics: Systemic pharmacological pain relief remains the mainstay.
- Supportive Measures: Rest, application of ice, and encouragement of deep breathing exercises.
- Incentive Spirometry: Promoted in all patients to maintain lung expansion and ward off atelectasis.
- Regional Anesthesia Techniques
To further improve comfort and respiratory mechanics, ultrasound-guided nerve blocks are employed according to fracture location:
- Serratus Anterior Plane Block for anterolateral rib fractures
- Thoracic Paravertebral Block for posterior rib fractures
- Surgical Intervention Reserved for complex cases-such as flail chest or fractures with risk of organ injury-where stabilization or repair may be necessary.
- Identified Gap Despite these options, thoracic surgeons currently lack a standardized, procedure-specific pain management protocol beyond systemic analgesics, highlighting a need for consensus guidelines that integrate pharmacological and regional techniques.
Read the detailed description
Thoracic trauma is a major traumatic injury throughout the world, and it has very high incidence in developing countries. Thoracic trauma is often associated with significant morbidity and mortality. Morbidity is due to atelectasis, pneumonia, and respiratory failure as a sequence of hypoventilation.
Most important factor in preventing complications in these patients is pain management. There are different lines of management of multiple rib fractures; conservative therapy is a common line of management which includes appropriate analgesic, rest, and ice.
The use of an incentive spirometer should be encouraged to prevent pulmonary atelectasis and splinting.
Nerve block can also be applied to aid in pain control, surgery may also be a line of management for complicated cases.
The type of nerve block differs according to the site of the fracture; Ultrasound-Guided Serratus Anterior Plane Block is often used for anterolateral rib fractures and Ultrasound-Guided Thoracic Paravertebral Block is used for posterior rib fractures.
The problem here is that ; There is no pain management protocol to be done by thoracic surgeons other than pharmacological analgesics.
This randomized prospective study will be performed in Assiut University Hospitals on two groups of trauma patients, each group is 37 patients; one will undergo nerve block by injection of Lidocaine (7mg/kg) with Epinephrine 1:100000 under ultrasonographical guidance and the other will receive pharmacological analgesics (Oral Paracetamol (500mg/6hr), IV Ketolac (15mg/6hr) and IV perfelgan (1gm/6hr)).
Then improvement in patients pain score, intercostal tube duration in days and total hospital stay in days, patient satisfaction using questionnaire will be assessed.
- Conditions
- Multiple Rib Fractures
- Being tested
- Nerve block with Lidocain, pharmacological analgesics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve block with LidocainProcedure or surgery
Injection of Lidocaine (7mg/kg) with Epinephrine 1:100000 under Ultrasonographical guidance
pharmacological analgesicsDrug
Oral Paracetamol (500mg/6hr), IV Ketolac (15mg/6hr) and IV perfelgan (1gm/6hr)
| Study group | Role | What they receive |
|---|---|---|
| nerve block | Active comparator | Not described Receives: Procedure: Nerve block with Lidocain |
| pharmacological analgesics | Active comparator | Not described Receives: Drug: pharmacological analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in patients pain score (neumerical score)
Measured: day 0, day 1 and day 3
Secondary outcomes (3)
improving intercostal tube duration in days
Measured: day 2, day 4 and day 6
improving total hospital stay in days
Measured: day 2, day 4 and day 6
improving patient satisfaction (questionnaire)
Measured: day 0, day 2, day 4 and day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Kotb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958549
- Sponsor's protocol ID
- RIBFRACTURE
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kring RM, Mackenzie DC, Wilson CN, Rappold JF, Strout TD, Croft PE. Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Improves Pain Control in Patients With Rib Fractures. J Ultrasound Med. 2022 Nov;41(11):2695-2701. doi: 10.1002/jum.15953. Epub 2022 Feb 2.
PubMed 35106815Yayik AM, Aydin ME, Tekin E, Ulas AB, Ahiskalioglu A. An alternative plane block for multiple rib fractures: Rhomboid Intercostal and Sub-Serratus block (RISS). Am J Emerg Med. 2019 Dec;37(12):2263.e5-2263.e7. doi: 10.1016/j.ajem.2019.158429. Epub 2019 Sep 6.
PubMed 31526541Hwang EG, Lee Y. Effectiveness of intercostal nerve block for management of pain in rib fracture patients. J Exerc Rehabil. 2014 Aug 31;10(4):241-4. doi: 10.12965/jer.140137. eCollection 2014 Aug.
PubMed 25210700Easter A. Management of patients with multiple rib fractures. Am J Crit Care. 2001 Sep;10(5):320-7; quiz 328-9.
PubMed 11548565
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Multiple Rib Fractures; Role of Nerve Block
- ClinicalTrials.gov ID
- NCT06958549
- Acronym / sponsor ID
- RIBFRACTURE
- Conditions
- Multiple Rib Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 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.
- Epidemiology \& Impact Thoracic trauma is a common and serious injury worldwide-especially in developing countries-and carries high rates of morbidity and mortality. Complications arise primarily from hypoventilation, which leads to atelectasis, pneumonia, and respiratory failure.
- Key to Reducing Complications: Pain Control Effective analgesia is the cornerstone of preventing respiratory complications. Inadequate pain relief causes patients to splint and hypoventilate, setting the stage for pulmonary collapse and infection.
- Conservative Management
- Analgesics: Systemic pharmacological pain relief remains the mainstay.
- Supportive Measures: Rest, application of ice, and encouragement of deep breathing exercises.
- Incentive Spirometry: Promoted in all patients to maintain lung expansion and ward off atelectasis.
- Regional Anesthesia Techniques
To further improve comfort and respiratory mechanics, ultrasound-guided nerve blocks are employed according to fracture location:
- Serratus Anterior Plane Block for anterolateral rib fractures
- Thoracic Paravertebral Block for posterior rib fractures
- Surgical Intervention Reserved for complex cases-such as flail chest or fractures with risk of organ injury-where stabilization or repair may be necessary.
- Identified Gap Despite these options, thoracic surgeons currently lack a standardized, procedure-specific pain management protocol beyond systemic analgesics, highlighting a need for consensus guidelines that integrate pharmacological and regional techniques.
Detailed description
Thoracic trauma is a major traumatic injury throughout the world, and it has very high incidence in developing countries. Thoracic trauma is often associated with significant morbidity and mortality. Morbidity is due to atelectasis, pneumonia, and respiratory failure as a sequence of hypoventilation.
Most important factor in preventing complications in these patients is pain management. There are different lines of management of multiple rib fractures; conservative therapy is a common line of management which includes appropriate analgesic, rest, and ice.
The use of an incentive spirometer should be encouraged to prevent pulmonary atelectasis and splinting.
Nerve block can also be applied to aid in pain control, surgery may also be a line of management for complicated cases.
The type of nerve block differs according to the site of the fracture; Ultrasound-Guided Serratus Anterior Plane Block is often used for anterolateral rib fractures and Ultrasound-Guided Thoracic Paravertebral Block is used for posterior rib fractures.
The problem here is that ; There is no pain management protocol to be done by thoracic surgeons other than pharmacological analgesics.
This randomized prospective study will be performed in Assiut University Hospitals on two groups of trauma patients, each group is 37 patients; one will undergo nerve block by injection of Lidocaine (7mg/kg) with Epinephrine 1:100000 under ultrasonographical guidance and the other will receive pharmacological analgesics (Oral Paracetamol (500mg/6hr), IV Ketolac (15mg/6hr) and IV perfelgan (1gm/6hr)).
Then improvement in patients pain score, intercostal tube duration in days and total hospital stay in days, patient satisfaction using questionnaire will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nerve block | Active comparator | Procedure: Nerve block with Lidocain |
| pharmacological analgesics | Active comparator | Drug: pharmacological analgesics |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All trauma adult patient (18-70 years) with multiple fracture ribs
Key exclusion criteria (2 listed)
- Patient with multiple fracture rib with anterior flail segment
- Significant head trauma
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 |
|---|---|---|
| Nerve block with LidocainInjection of Lidocaine (7mg/kg) with Epinephrine 1:100000 under Ultrasonographical guidance | Procedure or surgery | nerve block |
| pharmacological analgesicsOral Paracetamol (500mg/6hr), IV Ketolac (15mg/6hr) and IV perfelgan (1gm/6hr) | Drug | pharmacological analgesics |
Primary outcome
Improvement in patients pain score (neumerical score)
Time frame: day 0, day 1 and day 3
3 secondary outcomes
improving intercostal tube duration in days
Time frame: day 2, day 4 and day 6
improving total hospital stay in days
Time frame: day 2, day 4 and day 6
improving patient satisfaction (questionnaire)
Time frame: day 0, day 2, day 4 and day 6
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 6 May 2025.
- Background: PubMed 35106815Kring RM, Mackenzie DC, Wilson CN, Rappold JF, Strout TD, Croft PE. Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Improves Pain Control in Patients With Rib Fractures. J Ultrasound Med. 2022 Nov;41(11):2695-2701. doi: 10.1002/jum.15953. Epub 2022 Feb 2.
- Background: PubMed 31526541Yayik AM, Aydin ME, Tekin E, Ulas AB, Ahiskalioglu A. An alternative plane block for multiple rib fractures: Rhomboid Intercostal and Sub-Serratus block (RISS). Am J Emerg Med. 2019 Dec;37(12):2263.e5-2263.e7. doi: 10.1016/j.ajem.2019.158429. Epub 2019 Sep 6.
- Background: PubMed 25210700Hwang EG, Lee Y. Effectiveness of intercostal nerve block for management of pain in rib fracture patients. J Exerc Rehabil. 2014 Aug 31;10(4):241-4. doi: 10.12965/jer.140137. eCollection 2014 Aug.
- Background: PubMed 11548565Easter A. Management of patients with multiple rib fractures. Am J Crit Care. 2001 Sep;10(5):320-7; quiz 328-9.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nerve block with Lidocain and pharmacological analgesics in people with Multiple 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 2 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 6 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mostafa A Kotb (+201091703324, Moustafa.16266040@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in patients pain score (neumerical score) (time frame: day 0, day 1 and day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958549, which also lists 4 linked publications.
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 6 May 2025.