The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy. Participants randomized to the intervention group will receive the blocks with 0.2% ropivacaine administered via catheters placed in the superficial parasternal intercostal plane bilaterally under ultrasound guidance. Researchers will compare this group with a control group given 0.9% saline through similarly placed catheters. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.
This trial is comparing the use of 0.2% ropivacaine and 0.9% saline through a parasternal intercostal plane block and to measure whether there are any tangible changes in: 1. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion. Secondary outcomes will be: 2. cumulative postoperative opioid use from catheter insertion up to hospital discharge - measured as MME 3. median pain score - measured at rest and with coughing using a standardized numerical rating scale - for 72 hours post catheter insertion 4. delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
340
Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin. Following initial bolus dosing at the time of catheter placement (20 mL 0.2% ropivacaine), intermittent boluses of 10 mL 0.2% ropivacaine per side will be delivered via catheters q6-8 hours for 48 hours post-catheter insertion.
Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin. Following initial bolus dosing at the time of catheter placement (20 mL 0.9% Saline), intermittent boluses of 10 mL 0.9% Saline per side will be delivered via catheters q6-8 hours for 48 hours post-catheter insertion.
Foothills Medical Centre
Calgary, Alberta, Canada
RECRUITINGRoyal Columbian Hospital
Vancouver, British Columbia, Canada
RECRUITINGQEII Health Sciences Centre
Halifax, Nova Scotia, Canada
RECRUITINGSt. Michael's Hospital
Toronto, Ontario, Canada
RECRUITINGCumulative postoperative opioid use up to 72 hours
Postoperative opioid use measured using Milligram Morphine Equivalent(MME) from catheter insertion up to 72 hours.
Time frame: 72 hours after catheter insertion.
Median pain score
Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse)
Time frame: over 72 hours post-extubation
Cumulative post-operative opioid use
Opioid use measured using MME
Time frame: from time of catheter insertion until discharge from hospital
Delirium
assessed using Confusion Assessment Method (positive or negative; positive indicates delirium present) or Intensive Care Unit Delirium Screen Checklist Score (minimum 0, maximum 8; higher scores is worse; score greater than 3 is positive for delirium) or more than one dose antipsychotic drug or clinical diagnosis by psychiatrist.
Time frame: for 72 hours following catheter insertion
Quality of Recovery-15 Scale
Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome)
Time frame: 24-96 hours post surgery
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