Erector Spinae Plane Block in Uniportal VATS (ESPB-UVATS)

Effectiveness of Erector Spinae Plane Block in Uniportal VATS Lung Resections

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Pain; Thoracic Surgery; Post-Operative Pain, Chronic; Locoregional Anesthesia; Post-operative Complications; Uniportal Video Assisted Thoracic Surgery (U-VATS); Lung Resections
• Intervention / Treatment: Procedure: c-ESPB; Procedure: c-SAPB; Procedure: ICNB

Detailed Description

Patients will be enrolled into three groups:

1. continuous Erector Spinae Plane Block group (c-ESPB group)
2. continuous Serratus Anterior Plane Block group (c-SAPB group)

3. 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.

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

• Study Contact: Name: Giovanni Punzo, MD; Phone Number: 00390630153212; Email: giovanni.punzo@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Contact: Dania Nachira, MD; Email: dania.nachira@policlinicogemelli.it
    • Contact: Giovanni Punzo, MD; Email: giovanni.punzo@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
c-ESPB group; Postoperative analgesia ensured by continuous ultrasound-guided ESPB performed at the end of surgery.	Procedure: c-ESPB; 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 group; Postoperative analgesia ensured by continuous SAPB performed by surgeons at the end of surgery.	Procedure: c-SAPB; 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-group; Postoperative analgesia ensured by "one-shot" ICNB + continuous intravenous administration of tramadol by elastomeric pump.	Procedure: ICNB; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory and cardiac complications	Incidence of post-operative respiratory complications (i.e. atelectasis, pneumonia, arrhythmias, etc)	first 72 hours after extubation
pain at drain removal	severity of pain, measured by the visual analog scale (VAS), at chest drain removal	chest drain removal (third/fourth postoperative day)
incidence of chronic pain	presence of chronic neuropathic pain after surgery	12 weeks after surgery

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Dania Nachira, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Principal Investigator: Giovanni Punzo, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Thoracic Surgery; ESPB; Serratus Anterior Plane Block; Uniportal VATS; SAPB; Erectus Spinae Plane Block; ICNB; Intercostal Block
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain; Acute Pain; Postoperative Complications
• Other Study ID Numbers: 3921

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