Clinical trial NCT03781440: Regional Anesthesia for Cardiothoracic Enhanced Recovery
Official title: Regional Anesthesia for Cardiothoracic Enhanced Recovery for Patients Undergoing Cardiac Surgery Via Sternotomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use
Anesthesia, Local
Cardiac Disease
Pain, Acute
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Opioid Consumption
timeFrame: Duration of postoperative recovery (typically 1-2 weeks)
Secondary outcomes:
measure: Delirium and agitation post-operatively
timeFrame: Duration of ICU stay (typically 2-5 days)
measure: Determine post-operative pain scores
timeFrame: Duration of postoperative recovery (typically 1-2 weeks)
measure: Median time to extubation in patients with ESPB
timeFrame: Duration of postoperative recovery (typically 1-2 weeks)
measure: Length of stay in hospital
timeFrame: Duration of postoperative recovery (typically 1-2 weeks)
measure: Length of stay in ICU
timeFrame: Duration of postoperative recovery (typically 1-2 weeks)
measure: Quality of recovery at 72 hours
timeFrame: post-operative day 3
measure: Inflammatory biomarker analysis
timeFrame: First panel pre-incision; second panel 6hrs (+/-3hrs) post-procedure; third panel 24hrs (+/-3hrs) post-procedure; fourth panel 48hrs (+/-3hrs) post-procedure
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Jessica Brodt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Ban Tsui, MD
role: PRINCIPAL_INVESTIGATOR
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