Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03419117 |
| Other study ID # |
H18-00029 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 3, 2018 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
May 2021 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The erector spinae plane (ESP) block is a novel regional anesthetic technique for the
treatment of thoracic, cervical, and abdominal pain. This pilot study aims to investigate the
post-operative analgesic effectiveness of ultrasound guided single-shot ESP blocks for
patients undergoing minimally invasive thoracoscopic wedge resections of the lung in
comparison to those receiving conventional parental opioid analgesia alone. This will be
achieved through the use of objective measures including quality the 40 point Quality of
Recovery assessment (QoR-40) on postoperative day (POD) 1, visual-analogue pain scale (VAS)
in the post-anesthetic care unit (PACU) and at POD 1, and oral morphine-equivalent (OME)
opioid consumption in the PACU and at 24 hours post-operatively.
Description:
Purpose To investigate the postoperative analgesic effectiveness of the ultrasound-guided ESP
block compared to a placebo injection for patients undergoing thoracoscopic wedge resection
of the lung.
Hypothesis Thoracoscopic surgery patients who receive an ESP block in addition to current
standard of care, consisting of parenteral and enteral opioids and surgical wound
infiltration, will have a clinically significant improvement in their QoR-40 at POD 1 and
lower pain levels, as measured by VAS in the PACU on arrival and one hour after, and on POD
1, and OME opioid consumption in the PACU and at 24 hours post-operatively, in comparison to
those patients who receive the current standard of care along with a placebo injection.
Justification The ESP block is a novel regional anesthetic technique that has shown efficacy
in the management of thoracic pain as published in numerous case reports and observational
case series. To date, no randomized control trials exist of its efficacy in comparison to
conventional parental opioid analgesic management. Thoracoscopic wedge resections of the lung
are procedures not usually treated with regional analgesia techniques, but given the moderate
pain experienced by many patients, this surgical population will serve as a proof-of-concept
for the potential of improved post-operative analgesic and recovery profiles. Proof of
analgesic efficacy in this setting may allow a future head-to-head comparison with more
invasive analgesic techniques currently used for thoracic surgery such as epidural and
paravertebral catheterizations.
In undertaking this aim, we will measure a number of different metrics. The 40-item Quality
of Recovery Score (QoR-40) will be our primary objective as it provides a patient-centered
global measure of overall health in the postoperative period. It has been tested for validity
and reliability, and has undergone quantification for the minimal clinically important
difference. Other traditional metrics of analgesic performance including the VAS and 24-hour
post-op OME opioid consumption will also be monitored as secondary objectives.
Objectives
Primary Objective:
• Quality-of-Recovery 40 scale at POD 1.
Secondary Objectives:
- Cumulative OME opioid consumption intra-operatively and through PACU, and at 24 hours
post operatively.
- Visual analog pain scale assessments post-operatively in PACU on arrival, after 1 hour,
and at POD 1.
Research Design The study will be a prospective, single center, randomized,
placebo-controlled pilot study requiring 2 patient visits for assessment in the PACU and on
POD 1. One interim analysis for safety monitoring will be undertaken.
Sample Size Calculation and Statistical Methods No prior studies have been conducted to
calculate an exact sample size calculation. Based on similar work, we will power this study
on an expected difference of at least 10 points on the QoR-40 and a SD of 15 when comparing
the block to placebo. This is a clinically meaningful difference. Assuming an alpha level of
0.05 and a power of 0.80, our sample size is 74. With a 10% dropout rate we will require
recruitment of 82 patients. All outcomes will be analysed with the independent student
t-test.
