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

NCT04729712 | Completed

• 1 other identifier: ESPvsPVB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Regional Anesthesia; Erector Spinae Block; Thoracic Paravertebral Block; Quality of Recovery; Chronic Persistent Surgical Pain

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery (QoR-15) score between Anaesthesiologist-administered ultrasound guided Erector Spinae block and Surgeon-administered video-assisted Paravertebral block at 24 hours postoperative.

  QoR-15 is a 15-parameter questionnaire which has been recommended as an optimum tool to evaluate overall patient recovery after surgery and this includes postoperative pain. Participants will complete this questionnaire at 24 hours after their surgery. It is scored between 0 and 150, where 150 indicates that the patient has had an excellent recovery.

  24 hours postoperative

Secondary Outcomes (10)

• Chronic Persistent Surgical Pain (CPSP) after Minimally Invasive Thoracic Surgery (MITS)

  3 months postoperative

• Chronic Persistent Surgical Pain (CPSP) after Minimally Invasive Thoracic Surgery (MITS)

  3 months postoperative

• Pulmonary Function Assessment

  Preoperatively (day 0), postoperative day 1 and postoperative day 2

• Area Under the Curve (AUC) of Verbal Rating Score (VRS) for pain at rest and on deep inspiration versus time over 48 hours

  48 hours postoperative

• Time of administration of first intravenous opioid

  48 hours postoperative

Study Arms (2)

Anaesthesiologist-administered ultrasound guided Erector Spinae block with catheter insertion

ACTIVE COMPARATOR

Patient's will be randomised to this arm of the study. This group will receive an erector spinae block with catheter insertion under ultrasound guidance under general anaesthesia. This regional anaesthesia procedure will be performed by an Anaesthesiologist with experience in performing this block.

Procedure: Anaesthesiologist-administered ultrasound guided Erector Spinae block with catheter insertion

Surgeon-administered video-assisted Paravertebral block with catheter insertion

EXPERIMENTAL

Patient's will be randomised to this arm of the study. This group will receive a paravertebral block with catheter insertion under under thoracoscopic guidance. This regional anaesthesia procedure will be performed at the start of the operation by a surgeon with experience in performing this block.

Procedure: Surgeon-administered video-assisted Paravertebral block with catheter insertion

Interventions

Anaesthesiologist-administered ultrasound guided Erector Spinae block with catheter insertion PROCEDURE

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.

Anaesthesiologist-administered ultrasound guided Erector Spinae block with catheter insertion

Surgeon-administered video-assisted Paravertebral block with catheter insertion PROCEDURE

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.

Surgeon-administered video-assisted Paravertebral block with catheter insertion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female participants providing written informed consent
• American Society of Anesthesiologist grade 1-4
• Unilateral MITS (VATS and RATS) under general anaesthesia

You may not qualify if:

• Absence of written consent
• Unexpected conversion of MITS to open thoracotomy
• Contraindications to peripheral regional anaesthesia block: (Infection at local site, allergy to local anaesthesia medications, patient refusal, previous or existing neurological deficit, anticoagulated patients)
• Known dementia at time of MITS and inability to give informed consent
• Unexpected post-operative admission to ICU for continued ventilation
• History of opioid abuse

Sponsors & Collaborators

• Mater Misericordiae University Hospital: lead

Study Sites (2)

Mater Misericordiae University Hospital

Dublin, D07 R2WY, Ireland

Location

St Jame's University Hospital

Dublin, D08 NHy1, Ireland

Location

Related Publications (2)

• Moorthy A, Ni Eochagain A, Dempsey E, Wall V, Marsh H, Murphy T, Fitzmaurice GJ, Naughton RA, Buggy DJ. Postoperative recovery with continuous erector spinae plane block or video-assisted paravertebral block after minimally invasive thoracic surgery: a prospective, randomised controlled trial. Br J Anaesth. 2023 Jan;130(1):e137-e147. doi: 10.1016/j.bja.2022.07.051. Epub 2022 Sep 13.

  PMID: 36109206 DERIVED

• Moorthy A, Eochagain AN, Dempsey E, Buggy D. 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 pain: study protocol for a double-blinded randomised controlled trial. Trials. 2021 Dec 28;22(1):965. doi: 10.1186/s13063-021-05863-9.

  PMID: 34963493 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Interventions

Catheterization

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Donal Buggy, MB Bch BAO

  Professor of Anaesthesiology & Perioperative Medicine, Mater Misericordiae University Hospital,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The erector spinae plane and paravertebral blocks with catheter insertion will be performed after induction of general anaesthesia and therefore participants will be blinded to which intervention they have had. The outcome assessors for this study will be unaware as to which group the participant will be randomised to and therefore they will be blinded to which intervention the participant had received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow in Anaesthesia and Perioperative Medicine

Model Details: This will be a multicentre, prospective, double-blinded, randomised controlled clinical trial. This study will take place between three level four academic hospitals in Co.Dublin, Ireland. One group will receive an Anaesthesiologist-administered, ultrasound guided erector spinae plane catheter and the other group will receive a surgeon-administered, video-assisted paravertebral catheter.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: May 12, 2021
• Primary Completion: February 10, 2022
• Study Completion: May 5, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 5 years
• Access Criteria: Publications, reports or query requests from future investigators.

Locations

IE (2)