Erector Spinae BlockNCT07069101
Continuous Erector Spinae Block Versus Continuous Edge of Laminar Block on The Quality of Analgesia and Diaphragmatic Excursion in Patients With Multiple Rib Fractures
A study testing Erector spinae block and Edge of lamina block in people with Erector Spinae Block and Edge of Laminar Block, run by Tanta University at 1 site in Egypt.
Trial summary
This prospective randomized clinical trial aims to compare the effect of continuous erector spinae plane block versus continuous edge of laminar block on the quality of analgesia and diaphragmatic excursion in patients with unilateral traumatic multiple rib fractures. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Erector Spinae Block, Edge of Laminar Block, Analgesia
- What is being tested?
- Erector spinae block and Edge of lamina block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Dec 2025
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 21 and 65 years.
- Both sexes.
- With unilateral traumatic multiple fracture ribs (≥ 3), admitted to the surgical intensive care unit within the first day of trauma.
Who cannot join
- Patients' rejection.
- Body mass index ≥ 35 (kg/m2).
- Bleeding and Coagulation disorders.
- Known hypersensitivity to the study drugs.
- Vertebral deformity.
- Respiratory, cardiac, renal or hepatic dysfunction.
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- Patients with major trauma involving extra-thoracic structures (e.g., head, spine, pelvis, and abdominal visceral injuries).
- Mental or cognitive dysfunction,
- History of chronic analgesic or drug abuse.
- Local infection at the site of the block.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Heba A Muhammed, Master, 00201032901343, heba.abdelhamid@med.tanta.edu.eg
Mohammed M Abu El Yazed, MD
About this study
Official title: The Effect of Continuous Erector Spinae Block Versus Continuous Edge of Laminar Block on The Quality of Analgesia and Diaphragmatic Excursion in Patients With Multiple Rib Fractures. A Prospective Randomized Trail.
This prospective randomized clinical trial aims to compare the effect of continuous erector spinae plane block versus continuous edge of laminar block on the quality of analgesia and diaphragmatic excursion in patients with unilateral traumatic multiple rib fractures.
Read the detailed description
Rib fractures occur in up to 12% of all trauma patients, most commonly due to blunt thoracic trauma, and pose a significant health care burden with their associated morbidity and mortality.
The erector spinae plane block (ESB) is a myofascial plane technique in which a needle is inserted under ultrasound guidance deep to the erector spinae muscle group, allowing an infusion of local anesthetic to diffuse to both the dorsal and ventral rami of the spinal nerves, thereby supplying the rib cage. This technique can be used as a single-shot method or to facilitate the placement of a catheter, allowing for continuous infusion and/or intermittent bolus to provide long-lasting analgesia.
The edge of laminar block (ELB) is a novel technique in which local anesthetics are injected at the lateral edge of the lamina. It has been proven to provide sensory analgesia during rib fractures.
- Conditions
- Erector Spinae Block, Edge of Laminar Block, Analgesia, Diaphragmatic Excursion, Multiple Rib Fractures
- Being tested
- Erector spinae block, Edge of lamina block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae blockOther
Patients will receive continuous ipsilateral erector spinae plane block.
Edge of lamina blockOther
Patients will receive continuous ipsilateral edge of laminar block.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae group | Experimental | Patients will receive continuous ipsilateral erector spinae plane block. Receives: Other: Erector spinae block |
| Edge of lamina group | Experimental | Patients will receive continuous ipsilateral edge of laminar block. Receives: Other: Edge of lamina block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
If the Numeric Rating Scale (NRS) is 4 or more IV morphine 3mg will be given.
Measured: 4 days postoperatively
Secondary outcomes (6)
Degree of pain
The degree of pain will be assessed using the Numeric Rating Scale (NRS) at rest and on coughing will be assessed before the block, at 60 minutes after the block, and then every 8 hours for 4 days.
Measured: 4 days postoperatively
Diaphragmatic excursion
Diaphragmatic excursion will be assessed before the block, at 60 minutes after the block, and then every 8 hours for 4 days.
Measured: 4 days postoperatively
Incidence of adverse events
Incidence of adverse events such as hematoma, local anesthetic systemic toxicity, respiratory complications, pneumothorax, nausea, and vomiting.
Measured: 4 days postoperatively
Forced vital capacity
Forced vital capacity (FVC) will be assessed before the block, at 60 minutes after block, and then every 8 hours for 4 days.
Measured: 4 days postoperatively
Forced expiratory volume 1
Forced expiratory volume 1 (FEV1) will be assessed before the block, at 60 minutes after block, and then every 8 hours for 4 days.
Measured: 4 days postoperatively
Forced expiratory volume 1 (FEV1)/Forced vital capacity (FVC)
Forced expiratory volume 1 (FEV1)/Forced vital capacity (FVC) will be assessed before the block, at 60 minutes after block, and then every 8 hours for 4 days.
Measured: 4 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Nov 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae BlockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Abdel Hamid Muhammed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069101
- Sponsor's protocol ID
- 36265MD297/10/24
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Erector Spinae Block Versus Continuous Edge of Laminar Block on The Quality of Analgesia and Diaphragmatic Excursion in Patients With Multiple Rib Fractures. A Prospective Randomized Trail.
- ClinicalTrials.gov ID
- NCT07069101
- Acronym / sponsor ID
- 36265MD297/10/24
- Conditions
- Erector Spinae Block, Edge of Laminar Block, Analgesia, Diaphragmatic Excursion, Multiple Rib Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 16 Jul 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.
This prospective randomized clinical trial aims to compare the effect of continuous erector spinae plane block versus continuous edge of laminar block on the quality of analgesia and diaphragmatic excursion in patients with unilateral traumatic multiple rib fractures.
Detailed description
Rib fractures occur in up to 12% of all trauma patients, most commonly due to blunt thoracic trauma, and pose a significant health care burden with their associated morbidity and mortality.
The erector spinae plane block (ESB) is a myofascial plane technique in which a needle is inserted under ultrasound guidance deep to the erector spinae muscle group, allowing an infusion of local anesthetic to diffuse to both the dorsal and ventral rami of the spinal nerves, thereby supplying the rib cage. This technique can be used as a single-shot method or to facilitate the placement of a catheter, allowing for continuous infusion and/or intermittent bolus to provide long-lasting analgesia.
The edge of laminar block (ELB) is a novel technique in which local anesthetics are injected at the lateral edge of the lamina. It has been proven to provide sensory analgesia during rib fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae group | Experimental | Other: Erector spinae blockPatients will receive continuous ipsilateral erector spinae plane block. |
| Edge of lamina group | Experimental | Other: Edge of lamina blockPatients will receive continuous ipsilateral edge of laminar block. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 21 and 65 years.
- Both sexes.
- With unilateral traumatic multiple fracture ribs (≥ 3), admitted to the surgical intensive care unit within the first day of trauma.
Key exclusion criteria (10 listed)
- Patients' rejection.
- Body mass index ≥ 35 (kg/m2).
- Bleeding and Coagulation disorders.
- Known hypersensitivity to the study drugs.
- Vertebral deformity.
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 |
|---|---|---|
| Erector spinae blockPatients will receive continuous ipsilateral erector spinae plane block. | Other | Erector spinae group |
| Edge of lamina blockPatients will receive continuous ipsilateral edge of laminar block. | Other | Edge of lamina group |
Primary outcome
Total morphine consumption
Time frame: 4 days postoperatively
If the Numeric Rating Scale (NRS) is 4 or more IV morphine 3mg will be given.
6 secondary outcomes
Degree of pain
Time frame: 4 days postoperatively
Diaphragmatic excursion
Time frame: 4 days postoperatively
Incidence of adverse events
Time frame: 4 days postoperatively
Forced vital capacity
Time frame: 4 days postoperatively
Forced expiratory volume 1
Time frame: 4 days postoperatively
Forced expiratory volume 1 (FEV1)/Forced vital capacity (FVC)
Time frame: 4 days postoperatively
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 20 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae block and Edge of lamina block in people with Erector Spinae Block and Edge of Laminar Block, run by Tanta University at 1 site 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 20 Jul 2025. 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 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?
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 Heba A Muhammed, Master (00201032901343, heba.abdelhamid@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 4 days postoperatively). 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 20 Jul 2025.