Regional AnesthesiaNCT07535697
Ultrasound-Guided Erector Spinae Plane Block Versus Thoracoscopically-Guided Intercostal Nerve Block in Video-Assisted Thoracoscopic Surgery
A study testing Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB) and Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) in people with Regional Anesthesia and Video-assisted Thoracoscopic Surgery (VATS), run by Sana Klinikum Offenbach at 1 site in Germany.
Trial summary
Effective postoperative pain management is essential after thoracic surgery. Insufficient pain control may impair breathing and coughing, increasing the risk of pulmonary complications such as collapsed lungs (atelectasis) or pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia, Video-assisted Thoracoscopic Surgery (VATS), Erector Spinae Plane Block
- What is being tested?
- Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB) and Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 4 May 2026to 3 May 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- Adults (≥ 18 years of age)
- Elective video-assisted thoracoscopic surgery (VATS) for pulmonary resection (e.g., lobectomy, segmentectomy, wedge resection)
Who cannot join
- Lack of informed consent
- Language barrier
- Pregnancy or breastfeeding
- Known allergy to local anesthetics used in the study
- Infection at the injection site(s)
- History of complex chest wall surgery
Show all 17Show fewer
- Revision surgery with a prior operation within the last 6 months
- Intraoperative conversion to open thoracotomy
- Chronic pain syndrome
- Fibromyalgia
- Chronic opioid use
- Chronic alcohol abuse
- Chronic substance abuse (e.g., THC, amphetamines, cocaine)
- History of psychiatric disorders (e.g., depression, schizophrenia)
- Impaired consciousness, cognition, or ability to communicate
- Known coagulopathy (including platelet count < 80,000/µL or prolonged PTT/aPTT >1.5× the upper limit of normal)
- Ongoing therapeutic anticoagulation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
E. Park, MD contact
Germany1 site, 1 recruiting
- Recruiting
Sana Klinikum Offenbach
Offenbach, Hesse, 63069
Prof. Dr. H. Mutlak, 0049-69-8405-3802, haitham.mutlak@sana.de
E. Park, MD, eunji.park@sana.de
About this study
Official title: Prospective, Randomized Comparative Study of an Anesthesiological, Ultrasound-Guided "Erector Spinae Plane Block" (ESPB) Versus a Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) in "Video-Assisted Thoracoscopic" (VATS) Procedures, Evaluating Postoperative Analgesic Consumption, Postoperative Pain Perception, and Duration of the Procedure
Effective postoperative pain management is essential after thoracic surgery. Insufficient pain control may impair breathing and coughing, increasing the risk of pulmonary complications such as collapsed lungs (atelectasis) or pneumonia.
Although minimally invasive lung surgery (video-assisted thoracoscopic surgery, VATS) is less painful than open surgery, people can still have significant pain after the operation.
Read more
The goal of this randomized comparative study is to compare two commonly used regional anesthesia techniques for pain control after VATS in adults.
Researchers will compare an ultrasound-guided erector spinae plane block (ESPB), performed by anesthesiologists, to a thoracoscopically-guided intercostal nerve block (ICNB), performed by surgeons.
Participants will:
- Undergo elective VATS lung resection surgery
- Receive either ESPB or ICNB, according to random assignment
- Have the received amount of analgesics recorded during the first 24 hours
- Have their pain levels assessed at predefined time points after surgery
The main questions this study aims to answer are:
- Does ESPB result in similar analgesic consumption in the first 24 hours after surgery?
- Does ESPB provide similar postoperative pain relief compared to ICNB?
- Is the time needed to perform ESPB similar to ICNB?
Read the detailed description
Effective postoperative pain management is essential after thoracic surgery, as insufficient pain control may impair breathing and increase the risk of pulmonary complications such as atelectasis or pneumonia. Although video-assisted thoracoscopic surgery (VATS) is less invasive than open thoracotomy, patients may still experience significant postoperative pain.
This single-center, prospective, randomized non-inferiority study with two parallel arms compares two commonly used regional anesthesia techniques for perioperative pain management in adult participants undergoing elective VATS lung resections: the Erector Spinae Plane Block (ESPB) and the Intercostal Nerve Block (ICNB). Both techniques have been shown to reduce postoperative pain and opioid consumption. However, existing comparative studies have reported inconsistent results, and direct comparisons are limited by differences in techniques and study design.
After informed consent, participants are randomized preoperatively using a sealed-envelope system to receive either an ultrasound-guided ESPB or a thoracoscopically-guided ICNB.
The ESPB is performed by anesthesiologists before induction of general anesthesia, whereas the ICNB is performed intraoperatively by the surgeon under thoracoscopic visualization. Both interventions use a standardized dose of 25 mL ropivacaine 0.375% prior to the start of the surgical procedure. Perioperative anesthesia and analgesia management are standardized across both groups to ensure comparability and to minimize confounding effects.
The primary objective is to evaluate whether ESPB is non-inferior to ICNB with respect to postoperative analgesic consumption within the first 24 hours after surgery. The non-inferiority margin is defined as 5 mg piritramide within 24 hours. This margin was selected as it corresponds to the upper limit of a commonly used bolus dose in routine clinical practice and represents a clinically meaningful difference.
Secondary objectives include the comparison of postoperative pain perception within the first 24 hours and the duration of the chest wall block procedure. The incidence of postoperative nausea and vomiting (PONV) and procedure-related complications is also assessed.
The sample size calculation is based on the primary non-inferiority endpoint. Estimates of variability were derived from published data on postoperative opioid consumption following VATS. Using a one-sided significance level of 0.025, a statistical power of 90%, and a 1:1 allocation ratio, and accounting for a dropout rate of 10%, a total of 72 participants will be enrolled.
Statistical analysis will follow the non-inferiority design, comparing postoperative analgesic consumption between groups with respect to the predefined margin, while secondary outcomes will be analyzed using appropriate descriptive and inferential statistical methods.
- Conditions
- Regional Anesthesia, Video-assisted Thoracoscopic Surgery (VATS), Erector Spinae Plane Block, Intercostal Nerve Block
- Being tested
- Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB), Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB)
- Keywords
- Regional Anesthesia, Video-assisted Thoracoscopic Surgery (VATS), Erector Spinae Plane Block, ESPB, Intercostal Nerve Block, ICNB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB)Procedure or surgery
The ultrasound-guided Erector Spinae Plane Block (ESPB) is performed by experienced anesthesiologists prior to induction of general anesthesia and before the start of surgery. Standard sterile precautions are applied. The fifth and sixth thoracic vertebrae are identified using anatomical landmarks and, if needed, ultrasound guidance. An ultrasound probe is positioned in a paramedian sagittal orientation approximately 2 cm lateral to the spinous process to visualize relevant anatomical structures. An in-plane needle technique is used, advancing the needle in a cranial-to-caudal direction under continuous ultrasound visualization. The needle tip is positioned in the subfascial plane beneath the erector spinae muscle at the level of the transverse process. Correct positioning is confirmed using hydrodissection. The local anesthetic is administered incrementally under continuous ultrasound guidance with repeated negative aspiration. A total of 25 mL of ropivacaine 0.375% is injected.
Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB)Procedure or surgery
The thoracoscopically-guided Intercostal Nerve Block (ICNB) is performed by the surgeon intraoperatively immediately after insertion of the thoracoscope and before the start of surgery. Standard sterile precautions are applied. The block is performed percutaneously under continuous thoracoscopic visualization. The needle is advanced to the intercostal space, targeting the neurovascular bundle in the costal groove. Injections are performed at the level of the trocar insertion and in the two intercostal spaces cranial and caudal to it. The spread of the local anesthetic is visualized thoracoscopically to ensure correct placement and to avoid pleural perforation. A volume of 5 mL is administered per level, resulting in a total of 25 mL of ropivacaine 0.375%.
| Study group | Role | What they receive |
|---|---|---|
| Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB) | Active comparator | Not described Receives: Procedure: Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB) |
| Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) | Active comparator | Not described Receives: Procedure: Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the postoperative analgesic consumption within the first 24 hours after surgery
Postoperative analgesic consumption is recorded during the first 24 hours after surgery. Both total opioid consumption and use of non-opioid analgesics (e.g., metamizole, paracetamol) are documented.
Measured: First 24 hours after surgery
Secondary outcomes (2)
Assessment of the postoperative pain perception using the Numeric Rating Scale (NRS) pain scale
Postoperative pain is assessed using a standardized pain questionnaire (NRS Numeric Rating Scale Scale, Range: Generally 0-10, where 0 is "no pain" and 10 is "worst imaginable pain") administered by the hospital's anesthesiology pain service at predefined time points: 1 hour, 2 hours, 12 hours, and 24 hours after surgery.
The anesthesiology pain service remains blinded to the intervention performed.
Measured: First 24 hours after surgery
Duration of the chest wall block
Time required to perform the chest wall block, defined as the period from initial needle insertion to completion of the full local anesthetic dose administration.
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start4 May 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion3 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana Klinikum Offenbach
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Mutlak, Sana Klinikum Offenbach
- Investigators
- Haitham Mutlak, Prof. Dr., Principal investigator, Department of Anesthesiology, Intensive Care Medicine and Pain Therapy at Sana Klinikum Offenbach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535697
- Sponsor's protocol ID
- 2025-4161-evBO
- Other IDs
- 2025-4161-evBO
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 1 May 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Comparative Study of an Anesthesiological, Ultrasound-Guided "Erector Spinae Plane Block" (ESPB) Versus a Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) in "Video-Assisted Thoracoscopic" (VATS) Procedures, Evaluating Postoperative Analgesic Consumption, Postoperative Pain Perception, and Duration of the Procedure
- ClinicalTrials.gov ID
- NCT07535697
- Acronym / sponsor ID
- 2025-4161-evBO
- Conditions
- Regional Anesthesia, Video-assisted Thoracoscopic Surgery (VATS), Erector Spinae Plane Block, Intercostal Nerve Block
- Keywords
- Regional Anesthesia, Video-assisted Thoracoscopic Surgery (VATS), Erector Spinae Plane Block, ESPB, Intercostal Nerve Block, ICNB
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Sana Klinikum OffenbachUniversity, hospital or other
- Study start
- 4 May 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 3 May 2027 (estimated)
- First posted
- 17 Apr 2026 (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.
Effective postoperative pain management is essential after thoracic surgery. Insufficient pain control may impair breathing and coughing, increasing the risk of pulmonary complications such as collapsed lungs (atelectasis) or pneumonia.
Although minimally invasive lung surgery (video-assisted thoracoscopic surgery, VATS) is less painful than open surgery, people can still have significant pain after the operation.
The goal of this randomized comparative study is to compare two commonly used regional anesthesia techniques for pain control after VATS in adults.
Researchers will compare an ultrasound-guided erector spinae plane block (ESPB), performed by anesthesiologists, to a thoracoscopically-guided intercostal nerve block (ICNB), performed by surgeons.
Participants will:
- Undergo elective VATS lung resection surgery
- Receive either ESPB or ICNB, according to random assignment
- Have the received amount of analgesics recorded during the first 24 hours
- Have their pain levels assessed at predefined time points after surgery
The main questions this study aims to answer are:
- Does ESPB result in similar analgesic consumption in the first 24 hours after surgery?
- Does ESPB provide similar postoperative pain relief compared to ICNB?
- Is the time needed to perform ESPB similar to ICNB?
Detailed description
Effective postoperative pain management is essential after thoracic surgery, as insufficient pain control may impair breathing and increase the risk of pulmonary complications such as atelectasis or pneumonia. Although video-assisted thoracoscopic surgery (VATS) is less invasive than open thoracotomy, patients may still experience significant postoperative pain.
This single-center, prospective, randomized non-inferiority study with two parallel arms compares two commonly used regional anesthesia techniques for perioperative pain management in adult participants undergoing elective VATS lung resections: the Erector Spinae Plane Block (ESPB) and the Intercostal Nerve Block (ICNB). Both techniques have been shown to reduce postoperative pain and opioid consumption. However, existing comparative studies have reported inconsistent results, and direct comparisons are limited by differences in techniques and study design.
After informed consent, participants are randomized preoperatively using a sealed-envelope system to receive either an ultrasound-guided ESPB or a thoracoscopically-guided ICNB.
The ESPB is performed by anesthesiologists before induction of general anesthesia, whereas the ICNB is performed intraoperatively by the surgeon under thoracoscopic visualization. Both interventions use a standardized dose of 25 mL ropivacaine 0.375% prior to the start of the surgical procedure. Perioperative anesthesia and analgesia management are standardized across both groups to ensure comparability and to minimize confounding effects.
The primary objective is to evaluate whether ESPB is non-inferior to ICNB with respect to postoperative analgesic consumption within the first 24 hours after surgery. The non-inferiority margin is defined as 5 mg piritramide within 24 hours. This margin was selected as it corresponds to the upper limit of a commonly used bolus dose in routine clinical practice and represents a clinically meaningful difference.
Secondary objectives include the comparison of postoperative pain perception within the first 24 hours and the duration of the chest wall block procedure. The incidence of postoperative nausea and vomiting (PONV) and procedure-related complications is also assessed.
The sample size calculation is based on the primary non-inferiority endpoint. Estimates of variability were derived from published data on postoperative opioid consumption following VATS. Using a one-sided significance level of 0.025, a statistical power of 90%, and a 1:1 allocation ratio, and accounting for a dropout rate of 10%, a total of 72 participants will be enrolled.
Statistical analysis will follow the non-inferiority design, comparing postoperative analgesic consumption between groups with respect to the predefined margin, while secondary outcomes will be analyzed using appropriate descriptive and inferential statistical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB) | Active comparator | Procedure: Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB) |
| Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) | Active comparator | Procedure: Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of written informed consent
- Adults (≥ 18 years of age)
- Elective video-assisted thoracoscopic surgery (VATS) for pulmonary resection (e.g., lobectomy, segmentectomy, wedge resection)
Key exclusion criteria (17 listed)
- Lack of informed consent
- Language barrier
- Pregnancy or breastfeeding
- Known allergy to local anesthetics used in the study
- Infection at the injection site(s)
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 |
|---|---|---|
| Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB)The ultrasound-guided Erector Spinae Plane Block (ESPB) is performed by experienced anesthesiologists prior to induction of general anesthesia and before the start of surgery. Standard sterile precautions are applied. The fifth and sixth thoracic vertebrae are identified using anatomical landmarks and, if needed, ultrasound guidance. An ultrasound probe is positioned in a paramedian sagittal orientation approximately 2 cm lateral to the spinous process to visualize relevant anatomical structures. An in-plane needle technique is used, advancing the needle in a cranial-to-caudal direction under continuous ultrasound visualization. The needle tip is positioned in the subfascial plane beneath the erector spinae muscle at the level of the transverse process. Correct positioning is confirmed using hydrodissection. The local anesthetic is administered incrementally under continuous ultrasound guidance with repeated negative aspiration. A total of 25 mL of ropivacaine 0.375% is injected. | Procedure or surgery | Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB) |
| Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB)The thoracoscopically-guided Intercostal Nerve Block (ICNB) is performed by the surgeon intraoperatively immediately after insertion of the thoracoscope and before the start of surgery. Standard sterile precautions are applied. The block is performed percutaneously under continuous thoracoscopic visualization. The needle is advanced to the intercostal space, targeting the neurovascular bundle in the costal groove. Injections are performed at the level of the trocar insertion and in the two intercostal spaces cranial and caudal to it. The spread of the local anesthetic is visualized thoracoscopically to ensure correct placement and to avoid pleural perforation. A volume of 5 mL is administered per level, resulting in a total of 25 mL of ropivacaine 0.375%. | Procedure or surgery | Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) |
Primary outcome
Assessment of the postoperative analgesic consumption within the first 24 hours after surgery
Time frame: First 24 hours after surgery
Postoperative analgesic consumption is recorded during the first 24 hours after surgery. Both total opioid consumption and use of non-opioid analgesics (e.g., metamizole, paracetamol) are documented.
2 secondary outcomes
Assessment of the postoperative pain perception using the Numeric Rating Scale (NRS) pain scale
Time frame: First 24 hours after surgery
Duration of the chest wall block
Time frame: Perioperatively
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 1 May 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.
E. Park, MD contact
Haitham Mutlak, Prof. Dr. principal investigator
Department of Anesthesiology, Intensive Care Medicine and Pain Therapy at Sana Klinikum Offenbach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB) and Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) in people with Regional Anesthesia and Video-assisted Thoracoscopic Surgery (VATS), run by Sana Klinikum Offenbach at 1 site in Germany.
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 17 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 1 May 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 Germany. 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 Prof. Dr. H. Mutlak (0049-69-8405-3802, haitham.mutlak@sana.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the postoperative analgesic consumption within the first 24 hours after surgery (time frame: First 24 hours after surgery). 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 1 May 2026.