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NCT Number: NCT04892901

Erector Spinae Plane Block in Uniportal VATS

The main aim of this study is to compare the effectiveness of three alternative techniques (continuous Erectus Spinae Plane Block : c-ESPB; continuous Serratus Anterior Plane Block : c-SAPB; and Intercostal Nerve Block: ICNB) in reducing the severity of early postoperative pain after Uniportal-VATS lung resections. Primary outcomes will be opioid and other analgesic drugs consumption in the 72 hours after surgery, and static and dynamic pain scores, measured by the visual analog scale (VAS), at 6 pre-established time-points during the first 48 hours postoperatively. Further outcomes will be incidence of pulmonary and cardiac complications until patient's discharging, pain when removing drains, presence/absence of chronic neuropathic pain (12 weeks after surgery).

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Key information

Conditions

Thoracic Surgery Acute Pain Locoregional Anesthesia Lung Resections Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Operative Pain, Chronic Post-operative Complications Postoperative Complications Signs and Symptoms Uniportal Video Assisted Thoracic Surgery (U-VATS)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

About this study

Patients will be enrolled into three groups:

  • continuous Erector Spinae Plane Block group (c-ESPB group)
  • continuous Serratus Anterior Plane Block group (c-SAPB group)
  • Intercostal Nerve Block group (ICNB group)
  • In the c-ESPB group an ultrasound-guided ESPB will be performed by the attending anaesthesiologist at the end of surgery, immediately after the last surgical stitch and before extubation. After an initial bolus of 20 ml 0,2% ropivacaine, a catheter will be left into the fascial plane deep to the erector spinae muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic.
  • In the c-SAPB group SAPB will be performed by surgeons intraoperatively, immediately after chest wall disclosure, by injection of 20 ml 0,2% ropivacaine into the fascial plane deep to the Serratus Anterior muscle. After the initial bolus, a catheter will be left into the fascial plane deep to the Serratus Anterior muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic.
  • In the ICNB-group ICNB will be performed by surgeons intraoperatively, immediately after drain placement, by injection of 20 ml of 0,2% ropivacaine from within the chest under direct visualization of the intercostal spaces. The "one-shot" ICNB will be associated in this group with intravenous administration of tramadol (300 mg/48 h) by elastomeric pump.

The enrollment of patients into a specific group will depend on surgical variables (like disruption or not of serratus muscle/intercostal fascial planes), availability of an operator (surgeon/anesthesiologist) skilled in performing peripheral nerve blocks, logistic variables (availability of materials and ultrasound equipment).

The above mentioned primary/secondary outcome measures will be evaluated in each group and compared among them.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years

Exclusion criteria

  • Patients who will not sign the informed consent.
  • Patients scheduled for open thoracic surgery or not undergoing Uniportal-VATS resections.
  • Patients undergoing concomitant chest wall, diaphragm resection or mechanical/chemical pleurodesis.
  • History of previous thoracic surgery.
  • Patients with Chronic Post-Thoracotomy Pain.
  • Rib cage deformity or scoliosis.
  • Inherited or acquired coagulopathies.
  • History of allergy to drugs used during the study.
  • Age < 18 years.
  • Patients suffering from psychiatric or neurodegenerative diseases.

Treatment and study plan

c-ESPB

Procedure

In the c-ESPB group an ultrasound-guided ESPB will be performed by the attending anaesthesiologist at the end of surgery, immediately after the last surgical stitch and before extubation. After an initial bolus of 20 ml 0,2% ropivacaine, a catheter will be left in place into the fascial plane deep to the erector spinae muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic.

c-SAPB

Procedure

In the c-SAPB group SAPB will be performed by surgeons intraoperatively, immediately before the closure of chest wall muscle planes, by injection of 20 ml 0,2% ropivacaine into the fascial plane above the Serratus Anterior muscle. After the initial bolus, a catheter will be left in place into the superficial fascial plane of the Serratus Anterior muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic.

ICNB

Procedure

In the ICNB-group ICNB will be performed by surgeons intraoperatively, immediately before chest drain placement, by injection of 20 ml of 0,2% ropivacaine into the intercostal spaces (III-VII), below the parietal pleura, under direct visualization of the neurovascular bundle. The "one-shot" ICNB will be associated in this group with intravenous administration of tramadol (300 mg/48 h) by elastomeric pump.

Primary outcomes

  1. analgesic drug consumption

    Time frame: first 72 hours after extubation

    number of doses of analgesic drugs administered on patients' request during the postoperative period

  2. severity of early postoperative pain

    Time frame: first 48 hours after extubation

    static and dynamic pain scores, measured by the visual analog scale (VAS), at 6 pre-established time-points during the first 48 hours postoperatively.

Secondary outcomes

  1. respiratory and cardiac complications

    Time frame: first 72 hours after extubation

    Incidence of post-operative respiratory complications (i.e. atelectasis, pneumonia, arrhythmias, etc)

  2. pain at drain removal

    Time frame: chest drain removal (third/fourth postoperative day)

    severity of pain, measured by the visual analog scale (VAS), at chest drain removal

  3. incidence of chronic pain

    Time frame: 12 weeks after surgery

    presence of chronic neuropathic pain after surgery

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Effectiveness of Erector Spinae Plane Block in Uniportal VATS Lung Resections

Acronym: ESPB-UVATS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 19, 2021
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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