Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER)

• ClinicalTrials.gov Identifier: NCT03781440
• Recruitment Status: Active, not recruiting
• First Posted: December 19, 2018
• Last Update Posted: January 20, 2022
• Sponsor: Stanford University
• Information provided by (Responsible Party): Chi-Ho Ban Tsui, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opioid Use; Anesthesia, Local; Cardiac Disease; Pain, Acute	Procedure: Bilateral ESP catheter with lidocaine; Procedure: Bilateral ESP catheter with saline	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Regional Anesthesia for Cardiothoracic Enhanced Recovery for Patients Undergoing Cardiac Surgery Via Sternotomy
• Actual Study Start Date: January 1, 2020
• Actual Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: October 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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).	Procedure: 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).
Placebo Comparator: 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).	Procedure: 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).

Outcome Measures

Primary Outcome Measures :

1. Opioid Consumption [ Time Frame: Duration of postoperative recovery (typically 1-2 weeks) ]
   IV and PO opioid requirements converted to morphine equivalent

Secondary Outcome Measures :

1. Delirium and agitation post-operatively [ Time Frame: 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.
2. Determine post-operative pain scores [ Time Frame: 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.
3. Median time to extubation in patients with ESPB [ Time Frame: Duration of postoperative recovery (typically 1-2 weeks) ]
   duration in mechanical ventilation in hours
4. Length of stay in hospital [ Time Frame: Duration of postoperative recovery (typically 1-2 weeks) ]
   number of post-operative days spent in hospital
5. Length of stay in ICU [ Time Frame: Duration of postoperative recovery (typically 1-2 weeks) ]
   number of post-operative days spent in ICU
6. Quality of recovery at 72 hours [ Time Frame: 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.
7. Inflammatory biomarker analysis [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, California

Stanford University

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Jessica Brodt, MD; Stanford University
• Principal Investigator: Ban Tsui, MD; Stanford University

More Information

Publications:

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Zhu F, Lee A, Chee YE. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003587. doi: 10.1002/14651858.CD003587.pub2. Review.

Baikoussis NG, Papakonstantinou NA, Verra C, Kakouris G, Chounti M, Hountis P, Dedeilias P, Argiriou M. Mechanisms of oxidative stress and myocardial protection during open-heart surgery. Ann Card Anaesth. 2015 Oct-Dec;18(4):555-64. doi: 10.4103/0971-9784.166465. Review.

Giomarelli P, Scolletta S, Borrelli E, Biagioli B. Myocardial and lung injury after cardiopulmonary bypass: role of interleukin (IL)-10. Ann Thorac Surg. 2003 Jul;76(1):117-23.

Fragiadakis GK, Gaudillière B, Ganio EA, Aghaeepour N, Tingle M, Nolan GP, Angst MS. Patient-specific Immune States before Surgery Are Strong Correlates of Surgical Recovery. Anesthesiology. 2015 Dec;123(6):1241-55. doi: 10.1097/ALN.0000000000000887.

Gaudillière B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.

Eljezi V, D'Ostrevy N. Local Anesthetic Diffusion of Bilateral Sternal Block After Cardiac Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):418-419. doi: 10.1097/AAP.0000000000000577.

Chaudhary V, Chauhan S, Choudhury M, Kiran U, Vasdev S, Talwar S. Parasternal intercostal block with ropivacaine for postoperative analgesia in pediatric patients undergoing cardiac surgery: a double-blind, randomized, controlled study. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):439-42. doi: 10.1053/j.jvca.2011.10.012. Epub 2011 Dec 16.

Olivier JF, Bracco D, Nguyen P, Le N, Noiseux N, Hemmerling T; Perioperative Cardiac Surgery Research Group (PeriCARG). A novel approach for pain management in cardiac surgery via median sternotomy: bilateral single-shot paravertebral blocks. Heart Surg Forum. 2007;10(5):E357-62.

Cantó M, Sánchez MJ, Casas MA, Bataller ML. Bilateral paravertebral blockade for conventional cardiac surgery. Anaesthesia. 2003 Apr;58(4):365-70.

Lockwood GG, Cabreros L, Banach D, Punjabi PP. Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial. Perfusion. 2017 Oct;32(7):591-597. doi: 10.1177/0267659117715507. Epub 2017 Jun 7.

Svircevic V, Nierich AP, Moons KG, Diephuis JC, Ennema JJ, Brandon Bravo Bruinsma GJ, Kalkman CJ, van Dijk D. Thoracic epidural anesthesia for cardiac surgery: a randomized trial. Anesthesiology. 2011 Feb;114(2):262-70. doi: 10.1097/ALN.0b013e318201d2de.

Chakravarthy M, Thimmangowda P, Krishnamurthy J, Nadiminti S, Jawali V. Thoracic epidural anesthesia in cardiac surgical patients: a prospective audit of 2,113 cases. J Cardiothorac Vasc Anesth. 2005 Feb;19(1):44-8.

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

Kose HC, Kose SG, Thomas DT. Lumbar versus thoracic erector spinae plane block: Similar nomenclature, different mechanism of action. J Clin Anesth. 2018 Aug;48:1. doi: 10.1016/j.jclinane.2018.03.026. Epub 2018 Apr 9.

Wong J, Navaratnam M, Boltz G, Maeda K, Ramamurthi RJ, Tsui BCH. Bilateral continuous erector spinae plane blocks for sternotomy in a pediatric cardiac patient. J Clin Anesth. 2018 Jun;47:82-83. doi: 10.1016/j.jclinane.2018.03.020. Epub 2018 Apr 6.

Tsui BCH, Navaratnam M, Boltz G, Maeda K, Caruso TJ. Bilateral automatized intermittent bolus erector spinae plane analgesic blocks for sternotomy in a cardiac patient who underwent cardiopulmonary bypass: A new era of Cardiac Regional Anesthesia. J Clin Anesth. 2018 Aug;48:9-10. doi: 10.1016/j.jclinane.2018.04.005. Epub 2018 May 26.

Kain ZN, Fitch JC, Kirsch JR, Mets B, Pearl RG. Future of anesthesiology is perioperative medicine: a call for action. Anesthesiology. 2015 Jun;122(6):1192-5. doi: 10.1097/ALN.0000000000000680. Erratum in: Anesthesiology. 2015 Aug;123(2):492.

• Responsible Party: Chi-Ho Ban Tsui, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT03781440
• Other Study ID Numbers: 47647
• First Posted: December 19, 2018
• Last Update Posted: January 20, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Diseases; Acute Pain; Cardiovascular Diseases; Pain; Neurologic Manifestations; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action