Regional Anesthesia for Cardiothoracic Enhanced Recovery
- Conditions
- Opioid UseAnesthesia, LocalCardiac DiseasePain, Acute
- Interventions
- Procedure: Bilateral ESP catheter with lidocaineProcedure: Bilateral ESP catheter with saline
- Registration Number
- NCT03781440
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bilateral ESP catheter with Lidocaine Bilateral 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). Bilateral ESP catheter with saline Bilateral 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).
- Primary Outcome Measures
Name Time Method Opioid Consumption Duration of postoperative recovery (typically 1-2 weeks) IV and PO opioid requirements converted to morphine equivalent
- Secondary Outcome Measures
Name Time Method Length of stay in ICU Duration of postoperative recovery (typically 1-2 weeks) number of post-operative days spent in ICU
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.
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.
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
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States