Anesthesia, Local, Cardiac Disease, Opioid Use, Pain, Acute
Conditions
Brief summary
The erector spinae plane block (ESPB) is a novel regional analgesic technique that provides pain relief with a peripheral nerve block catheter. The goal of this study is to see if bilateral ESPB catheters can improve clinical outcomes in patients undergoing cardiac surgery via sternotomy, such as decreasing the duration of postoperative mechanical ventilation, need for intravenous opioid medications, length of stay in the intensive care unit (ICU), and improving pain scores.
Interventions
PROCEDUREBilateral ESP catheter with lidocaine
All participants will get the Erector Spinae Plane (ESP) catheters. Prior to transfer to the operating room, participants will receive bilateral ESP catheters at T7 level under ultrasound guidance. This arm is the treatment group and will receive lidocaine via alternating side automated infusion pump bolus dosing, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).
PROCEDUREBilateral ESP catheter with saline
All participants will get the Erector Spinae Plane (ESP) catheters. This arm is the control group and will have normal saline administered via ESP catheters, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Give consent to participate in study * planned sternotomy * specific procedures: CABG (coronary artery bypass grafting) or AVR (aortic valve repair or replacement) or MVR (mitral valve repair or replacement) or combination of any of 2 of these * Primary or first redo sternotomy
Exclusion criteria
* Participants who cannot give consent * Patients who are clinically unstable or require urgent/emergent intervention * more than1 prior sternotomy * planned aortic arch procedures * preoperative coagulopathy (INR \>1.5, PTT \>35) or ongoing anticoagulation (heparin infusion, therapeutic low molecular weight heparin, warfarin, dual antiplatelet therapy) * Severe ventricular dysfunction (left or right ventricle) * Symptomatic heart failure (systolic or diastolic)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | Duration of postoperative recovery (typically 1-2 weeks) | IV and PO opioid requirements converted to morphine equivalent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine post-operative pain scores | Duration of postoperative recovery (typically 1-2 weeks) | 11-point numerical rating scale (NRS) from 0-10, 0 signifying no pain, 10 signifying the worse pain. |
| Median time to extubation in patients with ESPB | Duration of postoperative recovery (typically 1-2 weeks) | duration in mechanical ventilation in hours |
| Length of stay in hospital | Duration of postoperative recovery (typically 1-2 weeks) | number of post-operative days spent in hospital |
| Delirium and agitation post-operatively | Duration of ICU stay (typically 2-5 days) | Richmond Agitation-Sedation Score from -5 to +4 (-5 is the most sedation, +4 is the least sedated. |
| Quality of recovery at 72 hours | post-operative day 3 | Survey based (Quality of Recover 15) patient reported outcomes. There are 15 questions based on a scale of 0-10 per questions, 0 signifying the worst outcome, 10 signifying the best, for a score range of 0-150. |
| Inflammatory biomarker analysis | First panel pre-incision; second panel 6hrs (+/-3hrs) post-procedure; third panel 24hrs (+/-3hrs) post-procedure; fourth panel 48hrs (+/-3hrs) post-procedure | Pro and anti-inflammatory biomarker panel at 4 time points perioperatively. We will be analyzing IL10 concentrations as an anti-inflammatory biomarker and IL6 and TN alpha as pro-inflammatory biomarkers in either a ELISA assay or Luminex. |
| Length of stay in ICU | Duration of postoperative recovery (typically 1-2 weeks) | number of post-operative days spent in ICU |
Countries
United States
Outcome results
None listed