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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-4161-evBO | Other Identifier | Ethik-Kommission Landesärztekammer Hessen |
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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:
The main questions this study aims to answer are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB) | Active Comparator |
| |
| Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | First 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative nausea and vomiting (PONV) | First 24 hours after surgery | |
| Incidence of complications | First 24 hours after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. H. Mutlak | Contact | 0049-69-8405-3802 | haitham.mutlak@sana.de | |
| E. Park, MD | Contact | eunji.park@sana.de |
| Name | Affiliation | Role |
|---|---|---|
| Haitham Mutlak, Prof. Dr. | Department of Anesthesiology, Intensive Care Medicine and Pain Therapy at Sana Klinikum Offenbach | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sana Klinikum Offenbach | Recruiting | Offenbach | Hesse | 63069 | Germany |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2026 |
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|
| Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB) | Procedure | 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%. |
|
| 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. | Perioperatively |
| Apr 10, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2026 | Apr 10, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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