A Phase 3 interventional study of Parasternal blocks and Standard of care in Coronary Artery Bypass Graft Surgery, sponsored by Jewish General Hospital. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-10.
Sponsored by Jewish General Hospital · Phase 3, Interventional, and Prevention
This is a randomized, double-blind, controlled clinical trial is to evaluate the duration of efficacy of parasternal blocks with the use of local anesthetic adjuncts for analgesia after coronary artery bypass grafting surgery.
This study will randomize patients to either standard pain control protocols or parasternal blocks after coronary artery bypass grafting-only surgery. This study will specifically examine the effectiveness and duration of analgesia of parasternal blocks with local anesthetic adjuncts, Dexamethasone 10mg and Dexmedetomidine 50mcg, added to the local anesthetic mixture
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Jewish General Hospital is the lead sponsor of 97 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will receive bilateral parasternal blocks at the end of cardiac surgery.
Drug: Parasternal blocks
Patients will receive all standard care as per the hospital protocols.
Drug: Standard of care
Parasternal block with Bupivacaine 0.25% + Epinephrine 1:200,000 x 60cc + Dexamethasone 5mg and Dexmedetomidine 50mcg
Also known as: pecto-intercostal fascial blocks
All standard management of postoperative pain, as per local protocols
Pain with inspirometry at 24 hours after surgery
Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain"
Time frame: 24 hours after surgery
Opioid consumption
Amount of opioid administered (mg of Dilaudid)
Time frame: 12, 24 and 48 hours after surgery
Amount of rescue analgesia administered
Amount of ketorolac or ketamine administered
Time frame: Total in the first 48 hours after surgery
Pain score at rest
Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain"
Time frame: 12, 24 and 48 hours after surgery
Pain score with inspirometry
Numerical Rating Scale (NRS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to "no pain" and 10 is equal to "the worst imaginable pain"
Time frame: 12 and 48 hours after surgery
Intensive Care Unit (ICU) Length of Stay
Time spent in the intensive care unit after surgery (days)
Time frame: From surgery until discharge from the ICU, assessed from the date of surgery up until 6 months after the completion of the study
Hospital Length of Stay
Time spent in the hospital after surgery (days)
Time frame: From the date of surgery up until discharge from hospital, followed from the date of surgery up until 6 months after the completion of the study
Inspirometry
Volume inspired on inspirometry
Time frame: 24 hours after surgery
Patient satisfaction with pain control
0 "extremely unsatisfied" to 10 "extremely satisfied"
Time frame: at 48 hours after surgery
Mobilization
Time from ICU arrival to the first mobilization to a chair
Time frame: From ICU arrival until first mobilization (approximately first 48 hours postoperatively)
Ambulation
Time from ICU arrival to the first mobilization to a chair
Time frame: From ICU arrival until first ambulation (approximately first 72 hours postoperatively)
Presence of postoperative vomiting
Vomiting after surgery
Time frame: first 48 hours after surgery
Incidence of bradycardia
Heart rate less than 60 beats per minute
Time frame: first 48 hours after surgery
Incidence of hyperglycemia
Glucose greater than 10 millimoles/liter
Time frame: first 48 hours after surgery
Incidence of a pneumothorax
Pneumothorax identified on chest x-ray
Time frame: first 48 hours after surgery
Local anesthetic toxicity
Local anesthetic toxicity, as diagnosed clinically
Time frame: first 48 hours after surgery
Postoperative Delirium
Delirium as defined by the "Confusion assessment method for the ICU" (CAM-ICU)
Time frame: first 48 hours after surgery
Narcotic prescription on discharge
Having a narcotic prescription on discharge
Time frame: Upon discharge from hospital after surgery (approximately 1 week after surgery)
Sternal pain at 3 months
Persistent pain at the sternum
Time frame: Three months after the day of surgery
Local anesthetic spread
Number of levels of spread of local anesthetic, as identified by ultrasound
Time frame: Immediately as intervention is performed
Ran from Jan 2022 to primary completion in Apr 2023, 15 months.
Of 39 non-industry phase 3 interventional studies under Pain, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 51. This study's 15 months is below that.
Counting every sponsor, half of 57 studies reached it within 23 months; a quarter within 11 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Jewish General Hospital