Clinical trial NCT04892901: Erector Spinae Plane Block in Uniportal VATS
Official title: Effectiveness of Erector Spinae Plane Block in Uniportal VATS Lung Resections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Primary outcomes:
measure: analgesic drug consumption
timeFrame: first 72 hours after extubation
measure: severity of early postoperative pain
timeFrame: first 48 hours after extubation
Secondary outcomes:
measure: respiratory and cardiac complications
timeFrame: first 72 hours after extubation
measure: pain at drain removal
timeFrame: chest drain removal (third/fourth postoperative day)
measure: incidence of chronic pain
timeFrame: 12 weeks after surgery
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Dania Nachira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Giovanni Punzo, MD
role: PRINCIPAL_INVESTIGATOR
References: