Fracture RibNCT05898958
Rhomboid Intercostal and Sub-Serratus Block for Improving Pulmonary Function and Pain in Patients With Fracture Ribs
A study testing thoracic paravertebral block and rhomboid intercostal and subserratus block in people with Fracture Rib, run by Zagazig University at 2 sites in Egypt.
Trial summary
Rib fractures are seen in more than 50% of patient spresenting with blunt chest trauma and are associated with significant morbidity, long-term disability and mortality . Many of these adverse consequences are a result ofinadequately controlled pain which hinders respiration,leading to atelectasis, pneumonia and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fracture Rib
- What is being tested?
- thoracic paravertebral block and rhomboid intercostal and subserratus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Oct 2021to 20 Sep 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- writteninformedconsentfrom the patient.
- Patient with unilateral multiple rib fractures(≥3fractures). ASA I and II . Age 18-60 years old. Both gender. BMI 25- 30 Kg/m2. Cooperative patients.
Who cannot join
- Compromised airway. Any trauma in the patient that interfere with the positioning of patients for block.
- Patients who needed mechanical ventilation before or during the study. Patients with associated head trauma. Patient with hemodynamic instability and need inotropic support. Patient with abbreviated injury scale (AIS) in extremity more than 2 Peripheral neuropathy. Pathological coagulopathy. Infection at the injection site. Untreated pneumothorax. Disturbed conscious level. An allergy to local anesthetics used in this study. Endocrinaldiseases including DM
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Impact of Ultrasound-Guided Rhomboid Intercostal and Sub-Serratus Block Versus Thoracic Paravertebral Block on Improving Pulmonary Functions for Multiple Rib Fractures
Rib fractures are seen in more than 50% of patient spresenting with blunt chest trauma and are associated with significant morbidity, long-term disability and mortality .
Many of these adverse consequences are a result ofinadequately controlled pain which hinders respiration,leading to atelectasis, pneumonia and respiratory failure .
Read more
The early provision of adequate analgesia is thereforeparamount in the management of these patients. The cornerstones of analgesic management are oral andintravenous medications such as paracetamol, nonsteroidal anti-inflammatorydrugs(NSAIDs) and opioids.
Nevertheless, in patients with more significant injuries orcomorbidities, interventional procedures are often neededto provide adequate analgesia and avoid opioid-relatedadverse effects .
Read the detailed description
Paravertebral block (PVB), through injecting a local anaesthetic agent close towhere the spinal nerves exit the intervertebral foramina, can provide high quality ipsilateral, segmental, somatic, and sympathetic nerve blockad.
PVB is a successful regional method for amelioration of pain in patients undergoingesophagectomy, breastsurgery, thoracotomy, cardiacsurgery,hepatectomy,percutaneusnephrolithotomyand nephrectomy .Thoracic paravertebralblock(TPVB) has also been used for pain reliefof multiplerib fractures ( MRFs).
Rhomboid intercostal and sub-serratus block (RISS) is an alternative block for multiple rib fractures.
The rhomboid intercostal block was first described in 2016 . The region described is known as the triangle of auscultation that is bounded medially by inferior part of the trapezius, inferiorly by the superior border oflatissimusdorsi, and laterally by the medial border of the scapula. In this ultrasound-guided block, the local anesthetic drug is administered between the rhomboid major and the intercostal muscle fascia at the level of T6-T7 and provides analgesia of T3-T8 dermatomes .
Elsharkawy et al. described a modification to the rhomboid intercostal block to expand dermatomal coverage fromT2-T11 dermatomes. They describe theRISS (Rhomboid Intercostal and Sub-Serratus) block that is a twoinjection block of both the rhomboidintercostal and sub-serratusspace. After the first injection, theultrasound probe advances caudally and laterally distal to the inferior angle of the scapula, the second injection apply between the serratus and intercostal muscle fascia.
Because comparison betweenTPVB and RISS in patients with MRF has rarely been reported.Therefore, this study aimed to assess theeffect ofRISS on pain managementand pulmonary functions compared with TPVB in patients withMRFs.
- Conditions
- Fracture Rib
- Being tested
- thoracic paravertebral block, rhomboid intercostal and subserratus 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.
thoracic paravertebral blockProcedure or surgery
The block will be performed in the lateral position.After skin sterilization,the ultrasound transducerprobe (6-13-MHz high-frequency linear transducer) is positioned in the vertical plane ∼2.5 cm lateral tomarked spinous process with its orientation directedcranially. T.After local anesthetic infiltration, an 18-gauge Tuohy needle will be inserted into the paravertebral spacein an 'in plane' technique. After a negativeaspiration through the needle, 20 ml of 0.25%bupivacaine with 1: 200 000 epinephrine will be injected slowly over 3 min.A20-G epidural catheter will be threaded through Tuohyneedle and advanced 2-3 cm into the paravertebral space.Anyprocedure-related adverse effects will be noted, and thedermatomal loss of pin prick sensation will be testedover both sides.
rhomboid intercostal and subserratus blockProcedure or surgery
The ultrasound probe will be placed in the obliquesagittal plane orientation, 1-2 cm medial to the medial scapula at theT5-T6 level. The trapezius muscle, rhomboid major muscle, ribs, intercostal muscle and pleura will be visualized respectively using ultrasound.After local anesthetic infiltration, needle will be inserted from the cranial to the caudal direction using the in-plane technique. The needle will be advanced between the rhomboid major and intercostal muscle fascia. The location of the needle will be confirmed with 2 mL saline solution, 10 ml of 0.25% bupivacaine with 1 : 200 000 epinephrine will beinjected slowly over 3min.for the subserratus block 10 ml of 0.25%bupivacaine with 1 : 200 000 epinephrine will be injected betweenthe serratus and intercostal muscle fascia at level of t9.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic paravertebral block(TPVB) | Experimental | Procedure/Surgery: thoracic paravertebral block The block will be performed in the lateral position.After skin sterilization,the ultrasound transducerprobe (6-13-MHz high-frequency linear transducer) is positioned in the vertical plane ∼2.5 cm lateral tomarked spinous process with its orientation directedcranially. T.After local anesthetic infiltration, an 18-gauge Tuohy needle will be inserted into the paravertebral spacein an 'in plane' technique. After a negativeaspiration through the needle, 20 ml of 0.25%bupivacaine with 1: 200 000 epinephrine will be injected slowly over 3 min.A20-G epidural catheter will be threaded through Tuohyneedle and advanced 2-3 cm into the paravertebral space.Anyprocedure-related adverse effects will be noted, and thedermatomal loss of pin prick sensation will be testedover both sides. Receives: Procedure: thoracic paravertebral block |
| Rhomboid Intercostal , subserratus block (RISSB) | Experimental | The ultrasound probe will be placed in the obliquesagittal plane orientation, 1-2 cm medial to the medial scapula at theT5-T6 level. The trapezius muscle, rhomboid major muscle, ribs, intercostal muscle and pleura will be visualized respectively using ultrasound.After local anesthetic infiltration, needle will be inserted from the cranial to the caudal direction using the in-plane technique. The needle will be advanced between the rhomboid major and intercostal muscle fascia. The location of the needle will be confirmed with 2 mL saline solution, 10 ml of 0.25% bupivacaine with 1 : 200 000 epinephrine will beinjected slowly over 3min.for the subserratus block 10 ml of 0.25%bupivacaine with 1 : 200 000 epinephrine will be injected betweenthe serratus and intercostal muscle fascia at level of t9. Receives: Procedure: rhomboid intercostal and subserratus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test FEV1 by using Hand-held spirometry
Spirometry is the most frequently used measure of lung function and is a measure of volume against time . The spirometer will be used to measure pulmonary function tests namely; FEV1 .Forced expiratory volume (FEV1) measure show how much air a person can exhale in a forced breath during the first second.
Measured: 3 days
The visual analog scale (VAS)
The visual analog scale (VAS) will be used to assess pain severity and control. VAS is a simple assessment tool consisting of a 10-cmline, where 0=no pain at all, 1-2=mild pain intensity,3-5=moderate pain intensity, 6-8=severe pain intensity, and 9-10=worst pain was felt.(22)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start20 Oct 2021
- Primary completion20 Aug 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture RibStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Raafat Mansour Saif Elbalat, Zagazig University
- Investigators
- Sanaa A Eltohamy, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898958
- Sponsor's protocol ID
- 9001-17-10-2021
- Status last verified
- Apr 2026
- First submitted
- 14 May 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultrasound-Guided Rhomboid Intercostal and Sub-Serratus Block Versus Thoracic Paravertebral Block on Improving Pulmonary Functions for Multiple Rib Fractures
- ClinicalTrials.gov ID
- NCT05898958
- Acronym / sponsor ID
- 9001-17-10-2021
- Conditions
- Fracture Rib
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 12 Jun 2023 (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.
Rib fractures are seen in more than 50% of patient spresenting with blunt chest trauma and are associated with significant morbidity, long-term disability and mortality .
Many of these adverse consequences are a result ofinadequately controlled pain which hinders respiration,leading to atelectasis, pneumonia and respiratory failure .
The early provision of adequate analgesia is thereforeparamount in the management of these patients. The cornerstones of analgesic management are oral andintravenous medications such as paracetamol, nonsteroidal anti-inflammatorydrugs(NSAIDs) and opioids.
Nevertheless, in patients with more significant injuries orcomorbidities, interventional procedures are often neededto provide adequate analgesia and avoid opioid-relatedadverse effects .
Detailed description
Paravertebral block (PVB), through injecting a local anaesthetic agent close towhere the spinal nerves exit the intervertebral foramina, can provide high quality ipsilateral, segmental, somatic, and sympathetic nerve blockad.
PVB is a successful regional method for amelioration of pain in patients undergoingesophagectomy, breastsurgery, thoracotomy, cardiacsurgery,hepatectomy,percutaneusnephrolithotomyand nephrectomy .Thoracic paravertebralblock(TPVB) has also been used for pain reliefof multiplerib fractures ( MRFs).
Rhomboid intercostal and sub-serratus block (RISS) is an alternative block for multiple rib fractures.
The rhomboid intercostal block was first described in 2016 . The region described is known as the triangle of auscultation that is bounded medially by inferior part of the trapezius, inferiorly by the superior border oflatissimusdorsi, and laterally by the medial border of the scapula. In this ultrasound-guided block, the local anesthetic drug is administered between the rhomboid major and the intercostal muscle fascia at the level of T6-T7 and provides analgesia of T3-T8 dermatomes .
Elsharkawy et al. described a modification to the rhomboid intercostal block to expand dermatomal coverage fromT2-T11 dermatomes. They describe theRISS (Rhomboid Intercostal and Sub-Serratus) block that is a twoinjection block of both the rhomboidintercostal and sub-serratusspace. After the first injection, theultrasound probe advances caudally and laterally distal to the inferior angle of the scapula, the second injection apply between the serratus and intercostal muscle fascia.
Because comparison betweenTPVB and RISS in patients with MRF has rarely been reported.Therefore, this study aimed to assess theeffect ofRISS on pain managementand pulmonary functions compared with TPVB in patients withMRFs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic paravertebral block(TPVB) | Experimental | Procedure: thoracic paravertebral blockProcedure/Surgery: thoracic paravertebral block The block will be performed in the lateral position.After skin sterilization,the ultrasound transducerprobe (6-13-MHz high-frequency linear transducer) is positioned in the vertical plane ∼2.5 cm lateral tomarked spinous process with its orientation directedcranially. T.After local anesthetic infiltration, an 18-gauge Tuohy needle will be inserted into the paravertebral spacein an 'in plane' technique. After a negativeaspiration through the needle, 20 ml of 0.25%bupivacaine with 1: 200 000 epinephrine will be injected slowly over 3 min.A20-G epidural catheter will be threaded through Tuohyneedle and advanced 2-3 cm into the paravertebral space.Anyprocedure-related adverse effects will be noted, and thedermatomal loss of pin prick sensation will be testedover both sides. |
| Rhomboid Intercostal , subserratus block (RISSB) | Experimental | Procedure: rhomboid intercostal and subserratus blockThe ultrasound probe will be placed in the obliquesagittal plane orientation, 1-2 cm medial to the medial scapula at theT5-T6 level. The trapezius muscle, rhomboid major muscle, ribs, intercostal muscle and pleura will be visualized respectively using ultrasound.After local anesthetic infiltration, needle will be inserted from the cranial to the caudal direction using the in-plane technique. The needle will be advanced between the rhomboid major and intercostal muscle fascia. The location of the needle will be confirmed with 2 mL saline solution, 10 ml of 0.25% bupivacaine with 1 : 200 000 epinephrine will beinjected slowly over 3min.for the subserratus block 10 ml of 0.25%bupivacaine with 1 : 200 000 epinephrine will be injected betweenthe serratus and intercostal muscle fascia at level of t9. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- writteninformedconsentfrom the patient.
- Patient with unilateral multiple rib fractures(≥3fractures). ASA I and II . Age 18-60 years old. Both gender. BMI 25- 30 Kg/m2. Cooperative patients.
Key exclusion criteria (2 listed)
- Compromised airway. Any trauma in the patient that interfere with the positioning of patients for block.
- Patients who needed mechanical ventilation before or during the study. Patients with associated head trauma. Patient with hemodynamic instability and need inotropic support. Patient with abbreviated injury scale (AIS) in extremity more than 2 Peripheral neuropathy. Pathological coagulopathy. Infection at the injection site. Untreated pneumothorax. Disturbed conscious level. An allergy to local anesthetics used in this study. Endocrinaldiseases including DM
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 paravertebral blockThe block will be performed in the lateral position.After skin sterilization,the ultrasound transducerprobe (6-13-MHz high-frequency linear transducer) is positioned in the vertical plane ∼2.5 cm lateral tomarked spinous process with its orientation directedcranially. T.After local anesthetic infiltration, an 18-gauge Tuohy needle will be inserted into the paravertebral spacein an 'in plane' technique. After a negativeaspiration through the needle, 20 ml of 0.25%bupivacaine with 1: 200 000 epinephrine will be injected slowly over 3 min.A20-G epidural catheter will be threaded through Tuohyneedle and advanced 2-3 cm into the paravertebral space.Anyprocedure-related adverse effects will be noted, and thedermatomal loss of pin prick sensation will be testedover both sides. | Procedure or surgery | Thoracic paravertebral block(TPVB) |
| rhomboid intercostal and subserratus blockThe ultrasound probe will be placed in the obliquesagittal plane orientation, 1-2 cm medial to the medial scapula at theT5-T6 level. The trapezius muscle, rhomboid major muscle, ribs, intercostal muscle and pleura will be visualized respectively using ultrasound.After local anesthetic infiltration, needle will be inserted from the cranial to the caudal direction using the in-plane technique. The needle will be advanced between the rhomboid major and intercostal muscle fascia. The location of the needle will be confirmed with 2 mL saline solution, 10 ml of 0.25% bupivacaine with 1 : 200 000 epinephrine will beinjected slowly over 3min.for the subserratus block 10 ml of 0.25%bupivacaine with 1 : 200 000 epinephrine will be injected betweenthe serratus and intercostal muscle fascia at level of t9. | Procedure or surgery | Rhomboid Intercostal , subserratus block (RISSB) |
Primary outcome
Pulmonary function test FEV1 by using Hand-held spirometry
Time frame: 3 days
Spirometry is the most frequently used measure of lung function and is a measure of volume against time . The spirometer will be used to measure pulmonary function tests namely; FEV1 .Forced expiratory volume (FEV1) measure show how much air a person can exhale in a forced breath during the first second.
The visual analog scale (VAS)
Time frame: 3 days
The visual analog scale (VAS) will be used to assess pain severity and control. VAS is a simple assessment tool consisting of a 10-cmline, where 0=no pain at all, 1-2=mild pain intensity,3-5=moderate pain intensity, 6-8=severe pain intensity, and 9-10=worst pain was felt.(22)
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 23 Apr 2026.
- 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.
Sanaa A Eltohamy study director
Zagazig University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic paravertebral block and rhomboid intercostal and subserratus block in people with Fracture Rib, run by Zagazig University at 2 sites in Egypt.
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 2 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: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Pulmonary function test FEV1 by using Hand-held spirometry (time frame: 3 days). The study lists 2 primary outcomes in all. 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 23 Apr 2026.