Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04729712 |
| Other study ID # |
ESPvsPVB |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 12, 2021 |
| Est. completion date |
May 5, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Mater Misericordiae University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 Vincent's University
Hospital-SVUH and St Jame's 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 (e.g. 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 8.0 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 = 0.05 and Type
II error = 0.2 (80% power to detect this difference), then n=36 patients will be required in
each group. We aim to enroll n=40 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,
i.e. 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 he/she
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 2016/679). 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 <0.05 will be considered statistically significant.
Financing and Insurance/Indemnity: 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.
