Regional Anesthesia for Cardiothoracic Enhanced Recovery

Not Applicable

Active, not recruiting

• Conditions: Opioid Use; Anesthesia, Local; Cardiac Disease; Pain, Acute

• 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

Study Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-19
• Study Start: 2020-01-01
• Primary Completion: 2021-09-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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