Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain

• Status: Not yet recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

Summary

One of the most painful aspects of open heart surgery is the incision made through the skin and the sternum to access the heart (a "sternotomy"). Post-sternotomy pain is a potentially debilitating complication of surgery that slows recovery immediately after surgery and can lead to issues with chronic pain. Previous research has shown that by injecting local anesthesia in the pecto-intercostal fascial plane, the space between the pectoralis major and the intercostal muscles, pain relief can be provided. This study aims to evaluate whether continuous local anesthetic infusion through multi-orifice pecto-intercostal fascial plane block (PIFB) catheters can reduce acute sternal pain after cardiac surgery via a complete median sternotomy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

• Scheduled cardiac surgery patients

• Complete median sternotomy

• Adult (19 years old or older)

• English-speaking

Exclusion Criteria:

1. Preoperative Exclusion Criteria:

• Patient refusal

• Emergent surgery

• Inability to provide consent

• Inability to follow up via telephone

• Known preoperative coagulopathy i) Congenital coagulopathy ii) Congenital platelet disorders iii) Platelet count < 50 x 109 iv) International normalized ratio (INR) or activated partial thromboplastin time (aPTT) exceeding the upper range of normal in the absence of anticoagulant use v) Does not include active anticoagulant or antiplatelet use

• Predicted post-operative therapeutic anticoagulation within 48 hours.

• Skin disease over block insertion site that would prevent catheter securement

• Immunodeficiency including uncontrolled diabetes, as defined by HbA1C more than 8.5% (20)

• Preoperative advanced liver failure (as defined by Child-Pugh B or C) (21)

• Preoperative advanced renal failure (as defined by Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2)

• Opioid tolerance (as defined by morphine oral equivalent >60mg for a period of 7 days or longer pre-operatively) (22)

• Allergy to local anesthetic, acetaminophen, or hydromorphone

• Weight less than 60 kg

2. Postoperative Exclusion Criteria:

• Postoperative bleeding at time of randomization as defined by initial chest tube loss of >350 mL, >200 mL per hour loss, > 2 mL/kg/hour loss for 2 consecutive hours, or requiring return to the operating room for surgical management (23)

• Hemodynamic instability, as determined by CSICU attending anesthesiologist

• Anticipated mechanical ventilation of more than 24 hours

• Anesthesiologist unavailable to insert PIFB catheter within 4 hours of CSICU arrival