Erector Spinae Plane Block in Uniportal VATS

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

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).

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Effectiveness of Erector Spinae Plane Block in Uniportal VATS Lung Resections

Conditions

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

Being tested

c-ESPB, c-SAPB, ICNB

Keywords

ESPB, Erectus Spinae Plane Block, SAPB, Serratus Anterior Plane Block, ICNB, Intercostal Block, Uniportal VATS, Thoracic Surgery

Medical subject headings

Pain, Postoperative, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• c-ESPBProcedure or surgery

  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-SAPBProcedure or surgery

  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.

• ICNBProcedure or surgery

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. analgesic drug consumption

   number of doses of analgesic drugs administered on patients' request during the postoperative period

   Measured: first 72 hours after extubation

2. 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.

   Measured: first 48 hours after extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted19 May 2021
2. Study start1 Jan 2022
3. Primary completion30 May 2023
4. Study completion20 Dec 2023

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
• More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.