An interventional study of slow sternal retraction in Chronic Pain, sponsored by Dr. Tarit Saha. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Dr. Tarit Saha · Not applicable, Interventional, and Prevention
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.
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.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 326 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Dr. Tarit Saha is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
sternal retraction (which is required for exposure of the heart during coronary artery bypass graft surgery) will be performed gradually over 15 minutes
Procedure: slow sternal retraction
sternal retraction will be performed as per standard practice (sternum opened rapidly over 30 sec.)
the sternal retraction (which always need to be performed for coronary artery bypass graft surgery) will be achieved over 15 min instead of the usual 30 sec
Also known as: slow retraction
Incidence of chronic post-sternotomy pain
incidence of chronic post-sternotomy pain 6 months following coronary artery bypass graft surgery
Time frame: 6 months postoperatively
Incidence of chronic post-sternotomy pain
incidence of chronic pain
Time frame: 3 and 12 months postoperatively
severity of chronic postoperative pain
pain on NRS scale
Time frame: 3 months. 6 months, 1 year
severity of acute postoperative pain at rest and with coughing
pain on NRS scale
Time frame: daily while an inpatient up to 1 week postoperatively
analgesic consumption
Time frame: daily while an inpatient up to 1 week postoperatively, 1 week postoperatively, 3, 6 and 12 months postoperatively
quality of life with the Modified Brief Pain Inventory (BPI)
Time frame: 3, 6, 12 months postoperatively
pain quality with the Douleur Neuropathique Questionnaire (DN4)
Time frame: 3, 6 and 12 months postoperatively
pain quality with the McGill Pain Questionnaire-short form (MPQ-SF)
Time frame: 3, 6 and 12 months postoperatively
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Dr. Tarit Saha