Erector Spinae Plane Block in Uniportal VATS

NCT ID: NCT04892901

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-20

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).

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

c-ESPB group

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

c-ESPB

Intervention Type: 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 group

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

c-SAPB

Intervention Type: 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-group

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

ICNB

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dania Nachira, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Giovanni Punzo, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, , Italy

Countries

Italy

Other Identifiers

3921

Identifier Type: -

Identifier Source: org_study_id