Ultrasound-Guided Erector Spinae Plane Block Versus Thoracoscopically-Guided Intercostal Nerve Block in Video-Assisted Thoracoscopic Surgery

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.

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?

Study Overview

• Status: Recruiting
• Conditions: Erector Spinae Plane Block; Regional Anesthesia; Video-assisted Thoracoscopic Surgery (VATS); Intercostal Nerve Block
• Intervention / Treatment: Procedure: Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB); Procedure: Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof. Dr. H. Mutlak; Phone Number: 0049-69-8405-3802; Email: haitham.mutlak@sana.de
• Study Contact Backup: Name: E. Park, MD; Email: eunji.park@sana.de

Study Locations

• Germany
  • Hesse
    • Offenbach, Hesse, Germany, 63069
      • Recruiting
      • Sana Klinikum Offenbach
      • Contact: Prof. Dr. H. Mutlak; Phone Number: 0049-69-8405-3802; Email: haitham.mutlak@sana.de
      • Contact: E. Park, MD; Email: eunji.park@sana.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB)	Procedure: 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.
Active Comparator: Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB)	Procedure: 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	First 24 hours after surgery

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative nausea and vomiting (PONV)	First 24 hours after surgery
Incidence of complications	First 24 hours after surgery

Collaborators and Investigators

• Sponsor: Sana Klinikum Offenbach
• Investigators: Principal Investigator: Haitham Mutlak, Prof. Dr., Department of Anesthesiology, Intensive Care Medicine and Pain Therapy at Sana Klinikum Offenbach

Study record dates

Study Major Dates

• Study Start (Estimated): May 4, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 3, 2027

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Erector Spinae Plane Block; ESPB; Intercostal Nerve Block; ICNB; Video-assisted Thoracoscopic Surgery (VATS)
• Additional Relevant MeSH Terms: Surgical Procedures, Operative
• Other Study ID Numbers: 2025-4161-evBO (Other Identifier: Ethik-Kommission Landesärztekammer Hessen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No