Edge of Laminar BlockNCT07201285
Edge of Laminar Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery
A study testing Edge of laminar block and Erector spinae plane block in people with Edge of Laminar Block and Erector Spinae Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the ultrasound-guided edge of laminar block (ELB) and erector spinae plane block (ESPB) for postoperative analgesia in patients undergoing video-assisted thoracic surgery (VATS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Edge of Laminar Block, Erector Spinae Plane Block, Postoperative Analgesia
- What is being tested?
- Edge of laminar block and Erector spinae plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 12 Apr 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Undergoing video-assisted thoracic surgery (VATS) under general anesthesia.
Who cannot join
- History of allergies to local anesthetics.
- Opioid dependency.
- Bleeding or coagulation disorders.
- Psychiatric and neurological disorder.
- Local infection at the site of injection.
- Severe heart, lung, liver, and renal dysfunction.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Edge of Laminar Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Video-Assisted Thoracoscopic Surgery: A Randomized Clinical Trial
This study aims to compare the ultrasound-guided edge of laminar block (ELB) and erector spinae plane block (ESPB) for postoperative analgesia in patients undergoing video-assisted thoracic surgery (VATS).
Read the detailed description
Postoperative pain after thoracic surgery, which is attributed to muscle incisions, rib retractions, and intercostal nerve damage, may be severe enough to cause pulmonary complications, such as atelectasis, pneumonia, and increased oxygen consumption.
The erector spinae plane block (ESPB) is used for managing post-thoracotomy pain and has numerous advantages that make it an attractive alternative technique. The ESPB injects a local anaesthetic around the erector spinae muscle at approximately the level of the T5. It may be able to block the dorsal and ventral rami of the thoracic spinal nerves.
A novel technique of retrolaminar block (RLB) called the edge of laminar block (ELB) to provide sensory analgesia during rib fracture surgery.
- Conditions
- Edge of Laminar Block, Erector Spinae Plane Block, Postoperative Analgesia, Video-Assisted Thoracoscopic Surgery
- Being tested
- Edge of laminar block, Erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edge of laminar blockOther
Patients will receive edge of laminar block using 20ml of bupivacaine 0.25%.
Erector spinae plane blockOther
Patients will receive an erector spinae plane block using 20ml of bupivacaine 0.25%.
| Study group | Role | What they receive |
|---|---|---|
| ELB group | Experimental | Patients will receive edge of laminar block using 20ml of bupivacaine 0.25%. Receives: Other: Edge of laminar block |
| ESPB group | Experimental | Patients will receive an erector spinae plane block using 20ml of bupivacaine 0.25%. Receives: Other: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS)> 3 to be repeated after 30 min if pain persists until the NRS < 4.
Measured: 24 hours postoperatively
Secondary outcomes (6)
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated).
Measured: 24 hours postoperatively
Intraoperative fentanyl consumption
Additional fentanyl bolus dosages of 0.5 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline.
Measured: Intraoperatively
Heart rate
Heart rate will be recorded preoperatively, before performing of block, and every 15 min till the end of surgery.
Measured: Till the end of surgery (Up to 2 hours)
Mean arterial pressure
Mean arterial pressure will be recorded preoperatively, before performing of block, and every 15 min till the end of surgery.
Measured: Till the end of surgery (Up to 2 hours)
Degree of pain
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 8, 12, 18, and 24 h postoperatively.
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, pruritus, urinary retention, itching, constipation, or any other complication.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Oct 2025
- Primary completion12 Apr 2026
- Study completion12 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edge of Laminar 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 (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201285
- Sponsor's protocol ID
- 36264PR1336/8/25
- Status last verified
- Apr 2026
- First submitted
- 23 Sep 2025
- Last updated
- 22 Apr 2026
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Edge of Laminar Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Video-Assisted Thoracoscopic Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07201285
- Acronym / sponsor ID
- 36264PR1336/8/25
- Conditions
- Edge of Laminar Block, Erector Spinae Plane Block, Postoperative Analgesia, Video-Assisted Thoracoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 12 Apr 2026 (actual)
- Study completion
- 12 Apr 2026 (actual)
- First posted
- 1 Oct 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 study aims to compare the ultrasound-guided edge of laminar block (ELB) and erector spinae plane block (ESPB) for postoperative analgesia in patients undergoing video-assisted thoracic surgery (VATS).
Detailed description
Postoperative pain after thoracic surgery, which is attributed to muscle incisions, rib retractions, and intercostal nerve damage, may be severe enough to cause pulmonary complications, such as atelectasis, pneumonia, and increased oxygen consumption.
The erector spinae plane block (ESPB) is used for managing post-thoracotomy pain and has numerous advantages that make it an attractive alternative technique. The ESPB injects a local anaesthetic around the erector spinae muscle at approximately the level of the T5. It may be able to block the dorsal and ventral rami of the thoracic spinal nerves.
A novel technique of retrolaminar block (RLB) called the edge of laminar block (ELB) to provide sensory analgesia during rib fracture surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELB group | Experimental | Other: Edge of laminar blockPatients will receive edge of laminar block using 20ml of bupivacaine 0.25%. |
| ESPB group | Experimental | Other: Erector spinae plane blockPatients will receive an erector spinae plane block using 20ml of bupivacaine 0.25%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Undergoing video-assisted thoracic surgery (VATS) under general anesthesia.
Key exclusion criteria (7 listed)
- History of allergies to local anesthetics.
- Opioid dependency.
- Bleeding or coagulation disorders.
- Psychiatric and neurological disorder.
- Local infection at the site of injection.
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 |
|---|---|---|
| Edge of laminar blockPatients will receive edge of laminar block using 20ml of bupivacaine 0.25%. | Other | ELB group |
| Erector spinae plane blockPatients will receive an erector spinae plane block using 20ml of bupivacaine 0.25%. | Other | ESPB group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS)> 3 to be repeated after 30 min if pain persists until the NRS < 4.
6 secondary outcomes
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Heart rate
Time frame: Till the end of surgery (Up to 2 hours)
Mean arterial pressure
Time frame: Till the end of surgery (Up to 2 hours)
Degree of pain
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
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 22 Apr 2026.
- 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.
Related trials for Edge of Laminar Block
Recruiting
Continuous Erector Spinae Block Versus Continuous Edge of Laminar Block on The Quality of Analgesia and Diaphragmatic Excursion in Patients With Multiple Rib Fractures
Erector Spinae Block, Edge of Laminar Block
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edge of laminar block and Erector spinae plane block in people with Edge of Laminar Block and Erector Spinae Plane 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 4 inclusion and 7 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 22 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 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?
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?
Total morphine consumption (time frame: 24 hours 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 22 Apr 2026.