NCT07535697

Brief 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. 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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026May 2027

First Submitted

Initial submission to the registry

April 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

May 4, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 10, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Regional AnesthesiaVideo-assisted Thoracoscopic Surgery (VATS)Erector Spinae Plane BlockESPBIntercostal Nerve BlockICNB

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Assessment of the postoperative pain perception using the Numeric Rating Scale (NRS) pain scale

    First 24 hours after surgery

  • Duration of the chest wall block

    Perioperatively

Other Outcomes (2)

  • Incidence of postoperative nausea and vomiting (PONV)

    First 24 hours after surgery

  • Incidence of complications

    First 24 hours after surgery

Study Arms (2)

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)

Interventions

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.

Anesthesiological, Ultrasound-Guided "Erector Spine Plane Block" (ESPB)

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%.

Surgical, Thoracoscopically-Guided "Intercostal Nerve Block" (ICNB)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sana Klinikum Offenbach

Offenbach, Hesse, 63069, Germany

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Haitham Mutlak, Prof. Dr.

    Department of Anesthesiology, Intensive Care Medicine and Pain Therapy at Sana Klinikum Offenbach

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Dr. H. Mutlak

CONTACT

E. Park, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Anesthesiology

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 17, 2026

Study Start

May 4, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

May 3, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations