Erector Spinae Plane Block in Uniportal VATS

NCT04892901 | Completed

• 1 other identifier: 3921
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Thoracic Surgery; Uniportal Video Assisted Thoracic Surgery (U-VATS); Lung Resections; Post-Operative Pain, Chronic; Acute Pain; Post-operative Complications; Locoregional Anesthesia

Keywords

ESPB; Erectus Spinae Plane Block; SAPB; Serratus Anterior Plane Block; ICNB; Intercostal Block; Uniportal VATS; Thoracic Surgery

Outcome Measures

Primary Outcomes (2)

• analgesic drug consumption

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

  first 72 hours after extubation

• severity of early postoperative pain

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

  first 48 hours after extubation

Secondary Outcomes (3)

• respiratory and cardiac complications

  first 72 hours after extubation

• pain at drain removal

  chest drain removal (third/fourth postoperative day)

• incidence of chronic pain

  12 weeks after surgery

Study Arms (3)

c-ESPB group

Postoperative analgesia ensured by continuous ultrasound-guided ESPB performed at the end of surgery.

Procedure: c-ESPB

c-SAPB group

Postoperative analgesia ensured by continuous SAPB performed by surgeons at the end of surgery.

Procedure: c-SAPB

ICNB-group

Postoperative analgesia ensured by "one-shot" ICNB + continuous intravenous administration of tramadol by elastomeric pump.

Procedure: ICNB

Interventions

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-ESPB group

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.

c-SAPB group

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.

ICNB-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults patients (age \> 18 years) scheduled for Uniportal-VATS lung resections, regardless of whether for benign or malignant disease and for any type of lung resection (segmentectomy, lobectomy, atypical lung resection).

You may qualify if:

• Age \>18 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dania Nachira, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

• Giovanni Punzo, MD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 19, 2021
• Study Start: January 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: December 20, 2023
• Last Updated: August 15, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)