Post-operative Pain Clinical Trial
— SPIFFYOfficial title:
Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology
Verified date | December 2023 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is looking to see if a regional block placed on each side of the incision after surgery helps with pain relief. Ultrasound-guided pectointercostal fascia blocks will be placed at the conclusion of surgery following application of dressings. Patients will be in the supine position with the surgical drapes in place. The blocks are performed using a high frequency linear transducer with aseptic technique. The investigators hypothesize that placement of PIF blocks and catheters will decrease acute postoperative pain from midline sternotomy in fast track cardiac surgery patients compared to the current standard of care. A physician will place an ultrasound guided pecto-intercostal fascial plane blocks bilaterally at the conclusion of surgery. They will also leave a catheter, similar to a small IV, between the muscle layers where the freezing medication goes. This will let the investigators give more freezing medication over the first 24 hours after surgery. The freezing medication blocks the pain signals from travelling to your brain from your incision, which might help participants need fewer narcotics after surgery. Some of the research on this block shows a trend toward reduced pain, but the use of a catheter to allow repeat doses of freezing medication has not been studied. The investigators hope to show that this regional block means participants need less opioids (narcotics) in the first 2 days after their heart surgery. In order to see whether the regional block is helpful there will be two groups of study participants. Both groups will receive infusion catheters covered with opaque bandages however one group will receive the study drug (ropivacaine) and the other will not (placebo). To reduce the risks to placebo group participants, those participants will have a catheter taped to their skin surface under an opaque dressing. This will give the illusion of block placement without the risks of a needle poking through skin. Both groups will still be given pain medications by IV or by mouth as needed after the surgery.
Status | Terminated |
Enrollment | 1 |
Est. completion date | June 11, 2023 |
Est. primary completion date | June 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - adult patients presenting to the Mazankowski Heart Institute for operations via full midline sternotomy, i.e.: coronary artery bypass grafting, and/or single valve repair or single valve replacement who are expected to be fast track candidates post-operatively. - patients scheduled for cardiac bypass grafting and/or single valve surgery requiring cardiopulmonary bypass. Exclusion Criteria: - Unstable or fluctuating cardiac condition (acute MI, HF, tamponade, type A dissection, ongoing refractory arrhythmia, LVEF <40%, massive transfusion protocol, reinstitution of CPB or other mechanical support) - Alternative surgical approach (e.g. thoracotomy, mini sternotomy) - Repeat sternotomy or emergency surgery - Pregnancy or lactation - Age <18 - Chronic pain - Tolerance to opioids - Active alcohol misuse disorder, IVDU or cannabis use >1g/d - Allergy to local anesthetics - Inability to provide informed consent - High doses of steroids pre-operatively (>10 mg prednisone/day) |
Country | Name | City | State |
---|---|---|---|
Canada | Gerhardus Heart van Rensburg | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid consumption | Cumulative opioid consumption in milligrams of morphine in the first 12 hours after surgery. | 12 hours | |
Secondary | Opioid consumption in 24 hours | Amount of opioid consumed in 24 hours | 24 hours post-operatively | |
Secondary | Time to extubation | Time until ETT is removed post-operatively. | 24 hours | |
Secondary | Pain score | Pain score as reported using the numeric rating scale | Every 6 hours for 24 hours post-operatively | |
Secondary | ICU length of stay | Length of stay in ICU | 2 weeks | |
Secondary | Surgical site infection rate | Until hospital discharge | 4 weeks | |
Secondary | Local anesthetic systemic toxicity effects | As evidenced by: tinnitus, perioral numbness, metallic taste | 24 hours |
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