Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04729712
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2021-01-25
Brief Title:
Efficacy of Ultrasound Guided ESP Vs Video-assisted PVB Catheter Placement in Minimally Invasive Thoracic Surgery
Sponsor:
Mater Misericordiae University Hospital
Organization:
Mater Misericordiae University Hospital
Study Overview
Official Title:
Ultrasound Guided Erector Spinae Plane ESP Catheter Versus Video-assisted Paravertebral Catheter Placement in Minimally Invasive Thoracic Surgery MITS Comparing Continuous Infusion Analgesic Techniques on Early Quality of Recovery Respiratory Function and Chronic Persistent Surgical Pain A Multicentre Randomised Double-blind Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 wallrib cage would improve the patients 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 patients bedside and can precisely deliver the medication in question at a rate between 10-15 mlhr This infusion of local anaesthesia medication will continue for 48 hours after the operation and will be monitored by the hospitals 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 patients short term 1-2 days and longer-term 3 months recovery
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 wallrib cage would improve the patients 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 patients bedside and can precisely deliver the medication in question at a rate between 10-15 mlhr This infusion of local anaesthesia medication will continue for 48 hours after the operation and will be monitored by the hospitals 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 patients short term 1-2 days and longer-term 3 months recovery
Detailed Description:
Erector Spinae Plane ESP block has emerged as a new regional anaesthesia technique which has had promising early results in attenuating severe acute pain associated with Minimal Invasive Thoracic Surgery MITS In a recent randomised control trial among MITS patients single-shot ESP block improved Quality of Recovery score QoR-15 and reduced overall complications at 24 hr compared with single-shot serratus anterior plane block SAP
Paravertebral block PVB has been widely used for analgesia after thoracic surgery for over two decades because it reduces postoperative pain and opioid requirements When compared with systemic analgesia and alongside with epidural analgesia it is considered the gold standard for thoracic regional analgesia techniques Both ESP and PVB have usually been described as a single-shot technique However catheter techniques offer the prospect of flexibility and prolonged analgesia
Placement of a thoracic PVB catheter can be achieved by an anatomical landmark or ultrasound technique Ultrasound technique has a higher success rate and safer profile when compared to the landmark technique but is technically challenging However in MITS an opportunity arises for directly visualised placement of a PVB catheter by the surgeon under thoracoscopic guidance Insertion of the PVB catheter and verification by the surgeon under direct vision could be a more reliable and safer method but there are limited randomised controlled trials examining the efficacy of this technique Also there are limited clinical effectiveness trials on the catheter-based ESP analgesia technique using patient-centred outcomes Furthermore no study has evaluated the effect of acute analgesia over 24-48 hr with continuous regional nerve block on CPSP at 3 months after MITS
Therefore the investigators aim to complete a multicentre prospective double-blinded randomised controlled clinical trial to test the hypothesis that Anaesthesiologist-administered ultrasound guided ESP catheter analgesia is equivalent to surgeon-administered video-assisted PVB catheter analgesia in terms of early recovery QoR-15 respiratory spirometric function at 24-48 hr and CPSP at 3 months after MITS surgery
Study setting This study will take place between three level four academic hospitals in the Republic of Ireland Mater Misericordiae Univeristy Hospital-MMUH St Vincents University Hospital-SVUH and St James University Hospital-SJH
Standard of care Standard of care will be identical in both groups The only difference will be that one group will receive an anaesthesiologist ultrasound guided placement of an erector spinae ESP catheter and the other will receive a surgeon video-assisted placement of a paravertebral block PVB catheter Patients in both groups will be given a general anaesthetic as part of their care All patients will be intubated with a double-lumen endotracheal tube and a radial arterial line will be sited for continuous haemodynamic monitoring Venous access will be at the discretion of the consultant anaesthesiologist The haemodynamic goal will be to maintain a systolic blood pressure within 20 of baseline and to avoid a heart rate greater than 100 beats per minute Persistent hypertension and or tachycardia above this point will trigger an opioid oxycodone morphine or fentanyl to be given intravenously The frequency and dosage of this will be at the discretion of the anaesthesiology team
Study intervention Participants will be randomised into either the ESP or PVB group No other forms of regional analgesia techniques eg Intrathecal opioids epidural analgesia and subcutaneous infiltration of local anaesthetic will be used during this trial
Safety reporting Any unexpected complications that may arise from this trial will be documented and reported to the principal investigator surgical consultant and the relevant hospital patient safety board
Sample size and justification The primary outcome will be the QoR-15 score at 24 hours post operatively The established minimum clinically important difference in QoR-15 is 80 and the SD of QoR-15 scores is typically between 10-16 range of QoR score is 1-150 We have chosen a SD of 12 to reflect our study population Therefore assuming Type I error 005 and Type II error 02 80 power to detect this difference then n36 patients will be required in each group We aim to enroll n40 each group to allow for loss to follow up missing data or withdrawal of consent
Recruitment Potential participants for this trial will be identified by a member of the surgical anaesthetic or research team A list of patients scheduled to have MITS will be made available the day before the procedure These patients electronic medical records will undergo a preliminary review to determine if they are potential candidates for this trial ie if participants meet the inclusion criteria and have no exclusions
The suitable patient will be approached the evening before surgery if available Alternatively patients will be approached on the ward on the morning of surgery and their suitability to participate in the trial will be confirmed The purpose of the trial peripheral nerve blocks including benefits and risks and method of follow up will be explained to the patient A comprehensive and informative leaflet will be given to each patient and they will be afforded an adequate amount of time minimum 10 mins to study it Participants will be informed that their participation in the study is entirely voluntary and they will have the opportunity to withdraw from the study at any time and this will not affect the quality of care they receive Following this participants will be offered an opportunity to ask any relevant questions and voice any potential concerns If heshe professes an interest in participating in the trial written consent will be obtained This process will be completed before transferring the patient to the theatre environment
Study participants will be followed on Day 1 and Day 2 postoperatively for QoR-15 and spirometric score A member of the research team will phone the patient at 3 months after the date of surgery and they will be asked to complete two questionnaires to assess for CPSP BPI and SF-12
Record Keeping All patient data collected will be handled in accordance with European Union General Data Protection Regulations EU 2016679 Data will be initially collected manually and then transcribed onto Microsoft excel Data collected from each hospital site will be stored securely in the Department of Anaesthesiology at the respective hospital on a password-protected desktop computer stored in a locked office such that only investigators assigned to data processing and analysis will have access to
Statistical analysis The collected raw data will be initially inspected for any errors this includes but is not limited to double-entry errors missing data and data that was incorrectly entered Patients with missing or incorrect data will be excluded from the trial and this data will not be included in the final analysis The data will be tested for normal distribution according to the Shapiro-Wilk test Normally distributed data will be compared between the two groups using the unpaired student t-test and non-normal distributed data will be compared by using Mann-Whitney U test All data will be summarised as mean standard deviation and p value 005 will be considered statistically significant
Financing and InsuranceIndemnity Investigators in each hospital will be covered by the clinical indemnity scheme CIS No funding has been sought to conduct this clinical trial Existing resources available to the investigators are sufficient to meet the aims of the study
Paravertebral block PVB has been widely used for analgesia after thoracic surgery for over two decades because it reduces postoperative pain and opioid requirements When compared with systemic analgesia and alongside with epidural analgesia it is considered the gold standard for thoracic regional analgesia techniques Both ESP and PVB have usually been described as a single-shot technique However catheter techniques offer the prospect of flexibility and prolonged analgesia
Placement of a thoracic PVB catheter can be achieved by an anatomical landmark or ultrasound technique Ultrasound technique has a higher success rate and safer profile when compared to the landmark technique but is technically challenging However in MITS an opportunity arises for directly visualised placement of a PVB catheter by the surgeon under thoracoscopic guidance Insertion of the PVB catheter and verification by the surgeon under direct vision could be a more reliable and safer method but there are limited randomised controlled trials examining the efficacy of this technique Also there are limited clinical effectiveness trials on the catheter-based ESP analgesia technique using patient-centred outcomes Furthermore no study has evaluated the effect of acute analgesia over 24-48 hr with continuous regional nerve block on CPSP at 3 months after MITS
Therefore the investigators aim to complete a multicentre prospective double-blinded randomised controlled clinical trial to test the hypothesis that Anaesthesiologist-administered ultrasound guided ESP catheter analgesia is equivalent to surgeon-administered video-assisted PVB catheter analgesia in terms of early recovery QoR-15 respiratory spirometric function at 24-48 hr and CPSP at 3 months after MITS surgery
Study setting This study will take place between three level four academic hospitals in the Republic of Ireland Mater Misericordiae Univeristy Hospital-MMUH St Vincents University Hospital-SVUH and St James University Hospital-SJH
Standard of care Standard of care will be identical in both groups The only difference will be that one group will receive an anaesthesiologist ultrasound guided placement of an erector spinae ESP catheter and the other will receive a surgeon video-assisted placement of a paravertebral block PVB catheter Patients in both groups will be given a general anaesthetic as part of their care All patients will be intubated with a double-lumen endotracheal tube and a radial arterial line will be sited for continuous haemodynamic monitoring Venous access will be at the discretion of the consultant anaesthesiologist The haemodynamic goal will be to maintain a systolic blood pressure within 20 of baseline and to avoid a heart rate greater than 100 beats per minute Persistent hypertension and or tachycardia above this point will trigger an opioid oxycodone morphine or fentanyl to be given intravenously The frequency and dosage of this will be at the discretion of the anaesthesiology team
Study intervention Participants will be randomised into either the ESP or PVB group No other forms of regional analgesia techniques eg Intrathecal opioids epidural analgesia and subcutaneous infiltration of local anaesthetic will be used during this trial
Safety reporting Any unexpected complications that may arise from this trial will be documented and reported to the principal investigator surgical consultant and the relevant hospital patient safety board
Sample size and justification The primary outcome will be the QoR-15 score at 24 hours post operatively The established minimum clinically important difference in QoR-15 is 80 and the SD of QoR-15 scores is typically between 10-16 range of QoR score is 1-150 We have chosen a SD of 12 to reflect our study population Therefore assuming Type I error 005 and Type II error 02 80 power to detect this difference then n36 patients will be required in each group We aim to enroll n40 each group to allow for loss to follow up missing data or withdrawal of consent
Recruitment Potential participants for this trial will be identified by a member of the surgical anaesthetic or research team A list of patients scheduled to have MITS will be made available the day before the procedure These patients electronic medical records will undergo a preliminary review to determine if they are potential candidates for this trial ie if participants meet the inclusion criteria and have no exclusions
The suitable patient will be approached the evening before surgery if available Alternatively patients will be approached on the ward on the morning of surgery and their suitability to participate in the trial will be confirmed The purpose of the trial peripheral nerve blocks including benefits and risks and method of follow up will be explained to the patient A comprehensive and informative leaflet will be given to each patient and they will be afforded an adequate amount of time minimum 10 mins to study it Participants will be informed that their participation in the study is entirely voluntary and they will have the opportunity to withdraw from the study at any time and this will not affect the quality of care they receive Following this participants will be offered an opportunity to ask any relevant questions and voice any potential concerns If heshe professes an interest in participating in the trial written consent will be obtained This process will be completed before transferring the patient to the theatre environment
Study participants will be followed on Day 1 and Day 2 postoperatively for QoR-15 and spirometric score A member of the research team will phone the patient at 3 months after the date of surgery and they will be asked to complete two questionnaires to assess for CPSP BPI and SF-12
Record Keeping All patient data collected will be handled in accordance with European Union General Data Protection Regulations EU 2016679 Data will be initially collected manually and then transcribed onto Microsoft excel Data collected from each hospital site will be stored securely in the Department of Anaesthesiology at the respective hospital on a password-protected desktop computer stored in a locked office such that only investigators assigned to data processing and analysis will have access to
Statistical analysis The collected raw data will be initially inspected for any errors this includes but is not limited to double-entry errors missing data and data that was incorrectly entered Patients with missing or incorrect data will be excluded from the trial and this data will not be included in the final analysis The data will be tested for normal distribution according to the Shapiro-Wilk test Normally distributed data will be compared between the two groups using the unpaired student t-test and non-normal distributed data will be compared by using Mann-Whitney U test All data will be summarised as mean standard deviation and p value 005 will be considered statistically significant
Financing and InsuranceIndemnity Investigators in each hospital will be covered by the clinical indemnity scheme CIS No funding has been sought to conduct this clinical trial Existing resources available to the investigators are sufficient to meet the aims of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None