NCT04729712

Efficacy of Ultrasound Guided ESP Vs Video-assisted PVB Catheter Placement in Minimally Invasive Thoracic Surgery

Completed NA Last updated 20 May 2022

What this trial tests

NA trial testing Anaesthesiologist-administered ultrasound guided Erector Spinae block with catheter insertion in Regional Anesthesia Morbidity in 80 participants. Completed in 5 May 2022.

Timeline

12 May 2021

Primary endpoint
10 February 2022

5 May 2022

Quick facts

Lead sponsor	Mater Misericordiae University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	12 May 2021
Primary completion	10 February 2022
Estimated completion	5 May 2022
Sites	2 locations across Ireland

Drugs / interventions tested

• Anaesthesiologist-administered ultrasound guided Erector Spinae block with catheter insertion
• Surgeon-administered video-assisted Paravertebral block with catheter insertion

Conditions studied

• Regional Anesthesia Morbidity — all drugs for Regional Anesthesia Morbidity →
• Pain, Postoperative — all drugs for Pain, Postoperative →
• Pain, Chronic — all drugs for Pain, Chronic →

Sponsor

Mater Misericordiae University Hospital

Who can join

Adults 18 to 85, any sex, with Regional Anesthesia Morbidity or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Minimally Invasive Thoracic Surgery (MITS) is a surgical method used to perform lung surgery through small incisions between the ribs and includes both Video-Assisted Thoracic Surgery (VATS) and Robotic assisted Thoracic Surgery (RATS). MITS can cause a significant amount of postoperative pain and if this is not adequately controlled, it can delay the patient's recovery and it may be a precipitating factor for the development of Chronic Persistent Surgical Pain (CPSP).

Regional anaesthesia is the use of nerve numbing medications known as local anaesthetics to block sensations of pain from a specific area of the body. For MITS, blocking pain arising from the chest wall/rib cage would improve the patient's recovery after the operation and overall patient satisfaction.

There have been significant advancements made in thoracic (chest wall) regional anaesthesia techniques. Ultimately, this involves injecting local anaesthetics around the nerves that supply the chest wall. A single injection of these medications will only have a maximum effect for up to 12 hours and often this is considerably less. To prolong the pain free benefit, a thin tube known as a catheter will be placed so that the local anaesthesia medication can be continuously given by a specific mechanical pump designed for this purpose. This mechanical pump will be located at the patient's bedside and can precisely deliver the medication in question at a rate between 10-15 ml/hr. This infusion of local anaesthesia medication will continue for 48 hours after the operation and will be monitored by the hospital's pain team.

The primary aim of this study is to compare the efficacy of two techniques for thoracic regional anaesthesia after this type of surgery. Participants will be randomly assigned (like tossing a coin) to receive either an Anaesthesiologist ultrasound guided Erector Spinae Plane Block (ESP) with catheter insertion or surgeon video-assisted Paravertebral block (PVB) with catheter insertion. Both these regional anaesthesia techniques are well established in clinical practice, but there is little evidence published comparing them for this type of surgery, in terms of quality of patient's short term (1-2 days) and longer-term (3 months) recovery.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Postoperative recovery with continuous erector spinae plane block or video-assisted paravertebral block after minimally invasive thoracic surgery: a prospective, randomised controlled trial.
   Moorthy A, Ní Eochagáin A, Dempsey E, Wall V, et al · · 2023 · cited 75× · PMID 36109206 · DOI 10.1016/j.bja.2022.07.051
2. Ultrasound-guided erector spinae plane catheter versus video-assisted paravertebral catheter placement in minimally invasive thoracic surgery: comparing continuous infusion analgesic techniques on early quality of recovery, respiratory function and chronic persistent surgical pai
   Moorthy A, Eochagain AN, Dempsey E, Buggy D. · · 2021 · cited 10× · PMID 34963493 · DOI 10.1186/s13063-021-05863-9
3. Ultrasound Guided Erector Spinae Plane Catheter Versus Video-Assisted Paravertebral Catheter Placement in Minimally Invasive Thoracic Surgery: Comparing Continuous Infusion Analgesic Techniques on Early Quality of Recovery, Respiratory Function and Chronic Persistent Surgical Pai
   Moorthy A, Eochagain AN, Dempsey E, Buggy D. · · 2021 · DOI 10.21203/rs.3.rs-703831/v1