Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02697812 |
| Other study ID # |
ANAE-233-13 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2014 |
| Est. completion date |
December 2020 |
Study information
| Verified date |
May 2023 |
| Source |
Queen's University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In North America, almost ½ million people undergo coronary artery bypass graft surgery
annually and over 1/3rd develop chronic chest pain. The current study will randomize cardiac
surgery patients to undergo slow sternal retraction for heart exposure (over 15 min.) versus
standard-of-care (sternal opening over 30 seconds) and examine the incidence and severity of
chronic post-sternotomy pain (CPSP) and quality-of life 3, 6 and 12 months post-operatively.
The severity of acute post-operative pain will also be measured. Increased retraction time
reduces forces required, which should translate to reduced nerve/tissue damage. If effective,
this simple change in practice could be readily implemented with a major impact for patients
and the health care system overall.
Description:
The overall objective of the current investigation is to determine whether increasing the
time to sternal retraction to 15 minutes (from the standard ~30 sec), will result in reduced
acute and chronic post-sternotomy pain and an improved quality of life. The hypothesis here
is that increased time to sternal retraction will result in: reduced required force, less
physical trauma, less inflammation, and less nerve damage. Specifically, the hypothesis is
that slow steady sternal retraction (occurring over 15 minutes) will 1) reduce the incidence
of CPSP by 40% 2) reduce the severity of acute postoperative pain by at least 20-30% and 3)
significantly improve quality of life 6 months postoperatively.
The current investigation will be a prospective blinded, randomized, controlled trial.
Following institutional ethics approval and signed consent, eligible patients scheduled for
elective coronary artery bypass graft surgery will be randomly assigned (stratified by gender
and surgeon to ensure equality between groups) either to the Standard group (in which sternal
retraction occurs over ~30s) or the Slow group in which sternal retraction occurs over 15
minutes. Patients and research personnel performing the postoperative assessments will remain
blinded to group assignment until conclusion of the investigation. All other intra-operative
variables will be performed as per standard practice by the cardiac surgeons at Kingston
General Hospital. The extent of sternal retraction will be to the surgeon's discretion to
enable appropriate exposure of the heart to allow safe conduct of the operation but it will
be recorded in all cases.
The primary outcome measure will be the incidence of chronic post-sternotomy chest pain 6
months following CABG with median sternotomy. However, we will also measure the incidence of
CPSP at 3 and 12 months to determine the trajectory. Secondary outcomes will include: Pain
intensity (numeric rating scale-NRS) of chest pain (which differs from preoperative) at rest
and while coughing daily while in hospital until discharge and at 1 week postoperatively.
Analgesic consumption (morphine equivalents) daily while in hospital until discharge, 1 week
post-operatively and then at 3, 6, and 12 months postoperatively. Intra-operative data will
include time from initiation to full retraction, latency from full retraction to sternal
closure, width of sternal opening at full retraction. Pain quality, quality of life, and pain
interference with daily function at 3, 6 and 12 months post-operatively. All assessments
following discharge from the hospital will be via telephone calls from a research nurse
blinded to randomization assignment. In-hospital assessments will also be done by a research
nurse blinded to group assignment.
