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

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Completed

Conditions

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

Treatments

Procedure: c-ESPB
Procedure: ICNB
Procedure: c-SAPB

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

75 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Dania Nachira, MD; Giovanni Punzo, MD

Data sourced from clinicaltrials.gov

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