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

NCT04729712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Regional Anesthesia Morbidity
  • Pain, Postoperative
  • Pain, Chronic

Interventions

PROCEDURE

Anaesthesiologist-administered ultrasound guided Erector Spinae block with catheter insertion

Erector Spinae block: A bolus of 20 ml 0.375% Levobupivacaine will be administered into the erector spinae plane prior to surgical incision. A further bolus of 10 ml 0.25% Levobupivacaine will be given at skin closure if it has been greater than 1 hour after the first bolus of local anaesthetic medication. A continuous infusion of 0.125% Levobupivacaine will be commenced via the sited nerve catheter for postoperative analgesia. This will be started at 10 ml/hr and titrated to effect to a maximum rate of 15 ml/hr.

PROCEDURE

Surgeon-administered video-assisted Paravertebral block with catheter insertion

Paravertebral block: A bolus of 20 ml 0.375% Levobupivacaine will be administered into the paravertebral space after the thoracoscopic ports have been sited. A further bolus of 10 ml 0.25% Levobupivacaine will be given at skin closure if it has been greater than 1 hour after the first bolus of local anaesthetic medication. A continuous infusion of 0.125% Levobupivacaine will be commenced via the sited nerve catheter for postoperative analgesia. This will be started at 10 ml/hr and titrated to effect to a maximum rate of 15 ml/hr.

Sponsors & Collaborators

  • Mater Misericordiae University Hospital

    lead OTHER

Principal Investigators

  • Donal Buggy, MB Bch BAO · Professor of Anaesthesiology & Perioperative Medicine, Mater Misericordiae University Hospital,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2022-02-10
Completion
2022-05-05

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04729712 on ClinicalTrials.gov