Postoperative PainELB vs SPSIPBNCT07073495
Comparison of Edge Laminar Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Pain Management After VATS
An observational study of Postoperative Pain and Thoracic Surgery, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to compare the effectiveness of Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in managing postoperative pain after Video-Assisted Thoracoscopic Surgery (VATS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Thoracic Surgery, Video-assisted Thoracoscopic Surgery (VATS)
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 15 Dec 2025
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients (aged 18-75 years) scheduled for elective video-assisted thoracoscopic surgery (VATS) at [Your Hospital Name/Institution Name]. These patients will be categorized based on the regional anesthesia technique received (Edge Laminar Block or Serratus Posterior Superior Intercostal Plane Block) for postoperative pain management. Patients with ASA physical status I-III will be included, ensuring a relatively healthy surgical population.
Who may be able to join
- Adults aged 18-75 years Scheduled for elective video-assisted thoracoscopic surgery (VATS) American Society of Anesthesiologists (ASA) physical status I-III Ability to provide informed consen
Who cannot join
- Known allergy or contraindication to local anesthetics Chronic opioid use or chronic pain conditions Coagulopathy or use of anticoagulant therapy Infection at the injection site Severe hepatic or renal dysfunction Pregnancy or breastfeeding Inability to understand or complete pain assessment scales
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06
About this study
Official title: A Prospective Observational Study Comparing Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) for Postoperative Pain Management After Video-Assisted Thoracoscopic Surgery (VATS)
This prospective observational study aims to compare the effectiveness of Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in managing postoperative pain after Video-Assisted Thoracoscopic Surgery (VATS). The study will evaluate postoperative pain scores (VAS/NRS), opioid consumption, incidence of postoperative nausea and vomiting (PONV), additional analgesic requirements, and patient satisfaction between the two regional analgesic techniques. This research seeks to provide guidance for optimal postoperative pain management in VATS patients.
Read the detailed description
Video-Assisted Thoracoscopic Surgery (VATS) is a widely used minimally invasive surgical method in thoracic surgery. However, it is known to cause moderate to severe postoperative pain, which can lead to significant respiratory complications such as atelectasis and pneumonia by inhibiting deep breathing and coughing. Inadequate pain control also increases sympathetic nervous system activity, potentially leading to tachycardia, hypertension, and increased myocardial oxygen consumption, especially in patients with cardiac conditions. Furthermore, delayed mobilization due to pain can increase the risk of deep vein thrombosis (DVT) and pulmonary embolism, while insufficient acute pain management may contribute to chronic postoperative pain syndrome. These issues highlight the critical need for effective postoperative pain management. While traditional methods like thoracic epidural analgesia (TEA) and thoracic paravertebral block (TPVB) exist, they are often invasive. In this context, interfascial block techniques such as Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) emerge as safer and effective alternatives.
ELB effectively blocks both anterior and posterior branches of thoracic nerves, providing extensive dermatomal sensory loss. It is considered a safer alternative to TPVB due to a lower risk of damage to sensitive structures like the pleura or major vessels during needle placement. ELB has been shown to be effective in postoperative pain management and reducing opioid consumption in surgeries like VATS. SPSIPB, applied by injecting local anesthetic between the serratus posterior superior muscle and intercostal muscles, provides both anteroposterior and lateral thoracic analgesia, creating a broad sensory block area. Studies have reported that SPSIPB provides an effective sensory block between C3-T10 levels and significantly reduces postoperative pain scores.
Study Objectives:
The primary objective of this study is to compare the effectiveness of ELB and SPSIPB in postoperative pain management in patients undergoing VATS. The study will focus on the following specific aims:
To evaluate the effects of ELB and SPSIPB on postoperative pain scores (Visual Analog Scale/Numeric Rating Scale - VAS/NRS).
To compare the potential of both techniques in reducing postoperative opioid consumption.
To examine the incidence of postoperative nausea and vomiting (PONV). To assess secondary outcome measures such as the need for additional analgesics and patient satisfaction in the postoperative period.
This study aims to be one of the first prospective observational studies to directly compare the efficacy of ELB and SPSIPB. The results are expected to provide guidance for optimal postoperative pain management in VATS patients and contribute to a better understanding of the clinical role of these two techniques.
Study Design and Methodology:
This will be a prospective, observational, single-center study. Patient groups will be formed based on natural clinical practice, without randomization. No additional procedures, interventions, or treatment changes will be made to any patient within the scope of the study. All patients will be managed according to standard anesthesia protocols currently applied in the clinic, at the discretion of the responsible anesthesiologists. During the study period, patients undergoing VATS will receive the block protocol routinely preferred by the responsible anesthesiologists, and no intervention will be made by the researchers. This study will not implement a new protocol; rather, it involves prospectively recording data from an anesthesia pain management protocol that proceeds in its natural course.
Postoperative Follow-up:
Pain Assessment: Pain will be assessed using the Visual Analog Scale (VAS) at 1, 4, 12, and 24 hours postoperatively.
Opioid Consumption: The amount of opioid consumed within the first 48 hours will be recorded (as morphine equivalents).
Complications: Complications such as hypotension, pruritus, nausea, and vomiting will be monitored.
Mobilization: The time until first mobilization (sitting at bedside/walking) will be recorded.
Patient Satisfaction: Patient satisfaction and pain control will be monitored and recorded for 48 hours (using a 5-point Likert scale).
- Conditions
- Postoperative Pain, Thoracic Surgery, Video-assisted Thoracoscopic Surgery (VATS), Serratus Posterior Superior Intercostal Plane Block, Edge Laminar Block
- Keywords
- Edge Laminar Block (ELB), Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Video-Assisted Thoracoscopic Surgery (VATS), Postoperative Pain, Pain Assessment, Thoracic Surgery, Opioid Sparing, Interfascial Plane Blocks
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ELB Group | Patients undergoing VATS who received Edge Laminar Block (ELB) for postoperative pain management. ELB involves the injection of local anesthetic at the edge of the thoracic lamina as a regional anesthesia technique. The efficacy and safety of ELB will be evaluated in this group. | |
| SPSIPB Group | Patients undergoing VATS who received Serratus Posterior Superior Intercostal Plane Block (SPSIPB) for postoperative pain management. SPSIPB involves the injection of local anesthetic into the intercostal plane beneath the serratus posterior superior muscle. The efficacy and safety of SPSIPB will be evaluated in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity measured by Visual Analog Scale (VAS) at rest at 2, 6, 12, and 24 hours after surgery.
Pain intensity will be assessed using the Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary outcome is the comparison of VAS scores between the two groups at specified time points.
Measured: 2, 6, 12, and 24 hours postoperatively
Secondary outcomes (3)
Total opioid consumption (in mg morphine equivalents) within the first 24 hours after surgery
The total amount of opioids administered to each patient will be recorded and converted to morphine equivalents for comparison between groups.
Measured: First 24 hours postoperatively
Incidence of postoperative complications (e.g., nausea, vomiting, respiratory depression) within 24 hours after surgery.
The occurrence of common postoperative complications will be documented and compared between groups.
Measured: First 24 hours postoperatively
Patient satisfaction with pain management, assessed by a numerical rating scale (1-5) at 24 hours after surgery.
Patients will rate their satisfaction with pain management on a scale from 1 (not satisfied at all) to 5(completely satisfied).
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 posted18 Jul 2025
- Study start15 Jul 2025
- Primary completion15 Oct 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Cennet Caferoğlu, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073495
- Sponsor's protocol ID
- 2025-06/84
- Acronym
- ELB vs SPSIPB
- Status last verified
- Feb 2026
- First submitted
- 10 Jul 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Comparing Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) for Postoperative Pain Management After Video-Assisted Thoracoscopic Surgery (VATS)
- ClinicalTrials.gov ID
- NCT07073495
- Acronym / sponsor ID
- ELB vs SPSIPB / 2025-06/84
- Conditions
- Postoperative Pain, Thoracic Surgery, Video-assisted Thoracoscopic Surgery (VATS), Serratus Posterior Superior Intercostal Plane Block, Edge Laminar Block
- Keywords
- Edge Laminar Block (ELB), Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Video-Assisted Thoracoscopic Surgery (VATS), Postoperative Pain, Pain Assessment, Thoracic Surgery, Opioid Sparing, Interfascial Plane Blocks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 18 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 observational study aims to compare the effectiveness of Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in managing postoperative pain after Video-Assisted Thoracoscopic Surgery (VATS). The study will evaluate postoperative pain scores (VAS/NRS), opioid consumption, incidence of postoperative nausea and vomiting (PONV), additional analgesic requirements, and patient satisfaction between the two regional analgesic techniques. This research seeks to provide guidance for optimal postoperative pain management in VATS patients.
Detailed description
Video-Assisted Thoracoscopic Surgery (VATS) is a widely used minimally invasive surgical method in thoracic surgery. However, it is known to cause moderate to severe postoperative pain, which can lead to significant respiratory complications such as atelectasis and pneumonia by inhibiting deep breathing and coughing. Inadequate pain control also increases sympathetic nervous system activity, potentially leading to tachycardia, hypertension, and increased myocardial oxygen consumption, especially in patients with cardiac conditions. Furthermore, delayed mobilization due to pain can increase the risk of deep vein thrombosis (DVT) and pulmonary embolism, while insufficient acute pain management may contribute to chronic postoperative pain syndrome. These issues highlight the critical need for effective postoperative pain management. While traditional methods like thoracic epidural analgesia (TEA) and thoracic paravertebral block (TPVB) exist, they are often invasive. In this context, interfascial block techniques such as Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) emerge as safer and effective alternatives.
ELB effectively blocks both anterior and posterior branches of thoracic nerves, providing extensive dermatomal sensory loss. It is considered a safer alternative to TPVB due to a lower risk of damage to sensitive structures like the pleura or major vessels during needle placement. ELB has been shown to be effective in postoperative pain management and reducing opioid consumption in surgeries like VATS. SPSIPB, applied by injecting local anesthetic between the serratus posterior superior muscle and intercostal muscles, provides both anteroposterior and lateral thoracic analgesia, creating a broad sensory block area. Studies have reported that SPSIPB provides an effective sensory block between C3-T10 levels and significantly reduces postoperative pain scores.
Study Objectives:
The primary objective of this study is to compare the effectiveness of ELB and SPSIPB in postoperative pain management in patients undergoing VATS. The study will focus on the following specific aims:
To evaluate the effects of ELB and SPSIPB on postoperative pain scores (Visual Analog Scale/Numeric Rating Scale - VAS/NRS).
To compare the potential of both techniques in reducing postoperative opioid consumption.
To examine the incidence of postoperative nausea and vomiting (PONV). To assess secondary outcome measures such as the need for additional analgesics and patient satisfaction in the postoperative period.
This study aims to be one of the first prospective observational studies to directly compare the efficacy of ELB and SPSIPB. The results are expected to provide guidance for optimal postoperative pain management in VATS patients and contribute to a better understanding of the clinical role of these two techniques.
Study Design and Methodology:
This will be a prospective, observational, single-center study. Patient groups will be formed based on natural clinical practice, without randomization. No additional procedures, interventions, or treatment changes will be made to any patient within the scope of the study. All patients will be managed according to standard anesthesia protocols currently applied in the clinic, at the discretion of the responsible anesthesiologists. During the study period, patients undergoing VATS will receive the block protocol routinely preferred by the responsible anesthesiologists, and no intervention will be made by the researchers. This study will not implement a new protocol; rather, it involves prospectively recording data from an anesthesia pain management protocol that proceeds in its natural course.
Postoperative Follow-up:
Pain Assessment: Pain will be assessed using the Visual Analog Scale (VAS) at 1, 4, 12, and 24 hours postoperatively.
Opioid Consumption: The amount of opioid consumed within the first 48 hours will be recorded (as morphine equivalents).
Complications: Complications such as hypotension, pruritus, nausea, and vomiting will be monitored.
Mobilization: The time until first mobilization (sitting at bedside/walking) will be recorded.
Patient Satisfaction: Patient satisfaction and pain control will be monitored and recorded for 48 hours (using a 5-point Likert scale).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELB Group | – | –Patients undergoing VATS who received Edge Laminar Block (ELB) for postoperative pain management. ELB involves the injection of local anesthetic at the edge of the thoracic lamina as a regional anesthesia technique. The efficacy and safety of ELB will be evaluated in this group. |
| SPSIPB Group | – | –Patients undergoing VATS who received Serratus Posterior Superior Intercostal Plane Block (SPSIPB) for postoperative pain management. SPSIPB involves the injection of local anesthetic into the intercostal plane beneath the serratus posterior superior muscle. The efficacy and safety of SPSIPB will be evaluated in this group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients (aged 18-75 years) scheduled for elective video-assisted thoracoscopic surgery (VATS) at [Your Hospital Name/Institution Name]. These patients will be categorized based on the regional anesthesia technique received (Edge Laminar Block or Serratus Posterior Superior Intercostal Plane Block) for postoperative pain management. Patients with ASA physical status I-III will be included, ensuring a relatively healthy surgical population.
Key inclusion criteria (1 listed)
- Adults aged 18-75 years Scheduled for elective video-assisted thoracoscopic surgery (VATS) American Society of Anesthesiologists (ASA) physical status I-III Ability to provide informed consen
Key exclusion criteria (1 listed)
- Known allergy or contraindication to local anesthetics Chronic opioid use or chronic pain conditions Coagulopathy or use of anticoagulant therapy Infection at the injection site Severe hepatic or renal dysfunction Pregnancy or breastfeeding Inability to understand or complete pain assessment scales
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative pain intensity measured by Visual Analog Scale (VAS) at rest at 2, 6, 12, and 24 hours after surgery.
Time frame: 2, 6, 12, and 24 hours postoperatively
Pain intensity will be assessed using the Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary outcome is the comparison of VAS scores between the two groups at specified time points.
3 secondary outcomes
Total opioid consumption (in mg morphine equivalents) within the first 24 hours after surgery
Time frame: First 24 hours postoperatively
Incidence of postoperative complications (e.g., nausea, vomiting, respiratory depression) within 24 hours after surgery.
Time frame: First 24 hours postoperatively
Patient satisfaction with pain management, assessed by a numerical rating scale (1-5) at 24 hours after surgery.
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 17 Feb 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.
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?
An observational study of Postoperative Pain and Thoracic Surgery, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 17 Feb 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 Turkey (Türkiye). 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?
Postoperative pain intensity measured by Visual Analog Scale (VAS) at rest at 2, 6, 12, and 24 hours after surgery. (time frame: 2, 6, 12, and 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 17 Feb 2026.