Coronary Artery Bypass Graft Surgery
Conditions
Keywords
Cardiac surgery, Pain
Brief summary
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.
Detailed description
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
Interventions
Parasternal block with Bupivacaine 0.25% + Epinephrine 1:200,000 x 60cc + Dexamethasone 5mg and Dexmedetomidine 50mcg
DRUGStandard of care
All standard management of postoperative pain, as per local protocols
Sponsors
Jewish General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients coming for elective and urgent coronary artery bypass (CABG)-only surgery.
Exclusion criteria
* Patients with a history of regular opioid use. * Patients with a history of chronic pain. * Patients unable to provide consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain with inspirometry at 24 hours after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of rescue analgesia administered | Total in the first 48 hours after surgery | Amount of ketorolac or ketamine administered |
| Opioid consumption | 12, 24 and 48 hours after surgery | Amount of opioid administered (mg of Dilaudid) |
| Pain score at rest | 12, 24 and 48 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 |
| Pain score with inspirometry | 12 and 48 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 |
| Intensive Care Unit (ICU) Length of Stay | From surgery until discharge from the ICU, assessed from the date of surgery up until 6 months after the completion of the study | Time spent in the intensive care unit after surgery (days) |
| Hospital Length of Stay | 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 | Time spent in the hospital after surgery (days) |
| Inspirometry | 24 hours after surgery | Volume inspired on inspirometry |
| Patient satisfaction with pain control | at 48 hours after surgery | 0 extremely unsatisfied to 10 extremely satisfied |
| Mobilization | From ICU arrival until first mobilization (approximately first 48 hours postoperatively) | Time from ICU arrival to the first mobilization to a chair |
| Ambulation | From ICU arrival until first ambulation (approximately first 72 hours postoperatively) | Time from ICU arrival to the first mobilization to a chair |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hyperglycemia | first 48 hours after surgery | Glucose greater than 10 millimoles/liter |
| Incidence of a pneumothorax | first 48 hours after surgery | Pneumothorax identified on chest x-ray |
| Local anesthetic toxicity | first 48 hours after surgery | Local anesthetic toxicity, as diagnosed clinically |
| Postoperative Delirium | first 48 hours after surgery | Delirium as defined by the Confusion assessment method for the ICU (CAM-ICU) |
| Narcotic prescription on discharge | Upon discharge from hospital after surgery (approximately 1 week after surgery) | Having a narcotic prescription on discharge |
| Sternal pain at 3 months | Three months after the day of surgery | Persistent pain at the sternum |
| Local anesthetic spread | Immediately as intervention is performed | Number of levels of spread of local anesthetic, as identified by ultrasound |
| Incidence of bradycardia | first 48 hours after surgery | Heart rate less than 60 beats per minute |
| Presence of postoperative vomiting | first 48 hours after surgery | Vomiting after surgery |
Countries
Canada
Outcome results
None listed