Erector Spinae Plane Block in Uniportal VATS

Acute Pain Clinical Trial

— ESPB-UVATS  

Official title:

Effectiveness of Erector Spinae Plane Block in Uniportal VATS Lung Resections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892901
• Other study ID #: 3921
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Dania Nachira, MD
• Phone: 00390630155692
• Email: dania.nachira[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 1, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Locoregional Anesthesia
• Pain, Postoperative
• Post-operative Complications
• Postoperative Complications
• Thoracic Surgery

Intervention

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
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
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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesic drug consumption	number of doses of analgesic drugs administered on patients' request during the postoperative period	first 72 hours after extubation
Primary	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	respiratory and cardiac complications	Incidence of post-operative respiratory complications (i.e. atelectasis, pneumonia, arrhythmias, etc)	first 72 hours after extubation
Secondary	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)
Secondary	incidence of chronic pain	presence of chronic neuropathic pain after surgery	12 weeks after surgery