Erector Spinae Plane Block in Uniportal VATS

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

• Registration Number: NCT04892901
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-14
• Study First Posted: 2021-05-19
• Study Start: 2022-01-01
• Status Verified: 2022-03
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-05-30
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
severity of early postoperative pain	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.
analgesic drug consumption	first 72 hours after extubation	number of doses of analgesic drugs administered on patients' request during the postoperative period

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy