Clinical trial NCT03611374: Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study
Official title: Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) for Patients Undergoing Sternotomy for Congenital Heart Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defect
Congenital Heart Disease
Anesthesia, Local
Opioid Use
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 38
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. The goals of this study are to determine if bilateral erector spinae plane blocks (ESPB) after sternotomy for congenital heart repair in high risk children and adults can decrease outcomes such as duration of postoperative mechanical ventilation (MV), perioperative opioid consumption, days in the intensive care unit (ICU) and length of stay (LOS).


Eligibility criteria: Inclusion Criteria:

i) Ages 0-99 ii) Give consent/parental consent to participate in study iii) Patients undergoing sternotomy for congenital heart repair surgeries

Exclusion Criteria:

i) Participants who do not consent or have parental consent ii) Patients who are clinically unstable or require urgent/emergent intervention iii) Patients under 5kg

Primary outcomes:
measure: Median time to extubation in patients with ESPB
timeFrame: Duration of postoperative recovery (typically 1-2 weeks)
measure: Median Cardiovascular Intensive Care Unit (CVICU) LOS in patients with ESPB
timeFrame: Duration of postoperative recovery (typically 1-2 weeks)
measure: Determine average post-operative pain scores in patients with ESPB
timeFrame: Duration of postoperative recovery (typically 1-2 weeks)
measure: Determine opioid consumption
timeFrame: Duration of postoperative recovery (typically 1-2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
affiliation: Stanford University
name: Thomas Caruso, MD, MEd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. No abstract available.
citation: Ramamoorthy C, Haberkern CM, Bhananker SM, Domino KB, Posner KL, Campos JS, Morray JP. Anesthesia-related cardiac arrest in children with heart disease: data from the Pediatric Perioperative Cardiac Arrest (POCA) registry. Anesth Analg. 2010 May 1;110(5):1376-82. doi: 10.1213/ANE.0b013e3181c9f927. Epub 2010 Jan 26.
citation: Fukunishi T, Oka N, Yoshii T, Kobayashi K, Inoue N, Horai T, Kitamura T, Okamoto H, Miyaji K. Early Extubation in the Operating Room after Congenital Open-Heart Surgery. Int Heart J. 2018 Jan 27;59(1):94-98. doi: 10.1536/ihj.16-630. Epub 2018 Jan 15.
citation: Bhalla AK, Yehya N, Mack WJ, Wilson ML, Khemani RG, Newth CJL. The Association Between Inhaled Nitric Oxide Treatment and ICU Mortality and 28-Day Ventilator-Free Days in Pediatric Acute Respiratory Distress Syndrome. Crit Care Med. 2018 Nov;46(11):1803-1810. doi: 10.1097/CCM.0000000000003312.
citation: Agarwal HS, Wolfram KB, Saville BR, Donahue BS, Bichell DP. Postoperative complications and association with outcomes in pediatric cardiac surgery. J Thorac Cardiovasc Surg. 2014 Aug;148(2):609-16.e1. doi: 10.1016/j.jtcvs.2013.10.031. Epub 2013 Nov 23.
citation: Diaz LK. Anesthesia and postoperative analgesia in pediatric patients undergoing cardiac surgery. Paediatr Drugs. 2006;8(4):223-33. doi: 10.2165/00148581-200608040-00002.
citation: Anand KJ, Hickey PR. Halothane-morphine compared with high-dose sufentanil for anesthesia and postoperative analgesia in neonatal cardiac surgery. N Engl J Med. 1992 Jan 2;326(1):1-9. doi: 10.1056/NEJM199201023260101.
citation: Pollak U, Serraf A. Pediatric Cardiac Surgery and Pain Management: After 40 Years in the Desert, Have We Reached the Promised Land? World J Pediatr Congenit Heart Surg. 2018 May;9(3):315-325. doi: 10.1177/2150135118755977.
citation: Brix-Christensen V. The systemic inflammatory response after cardiac surgery with cardiopulmonary bypass in children. Acta Anaesthesiol Scand. 2001 Jul;45(6):671-9. doi: 10.1034/j.1399-6576.2001.045006671.x.
citation: Gaudilliere 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.
citation: Fragiadakis GK, Gaudilliere 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.
citation: Hickey PR, Hansen DD. High-dose fentanyl reduces intraoperative ventricular fibrillation in neonates with hypoplastic left heart syndrome. J Clin Anesth. 1991 Jul-Aug;3(4):295-300. doi: 10.1016/0952-8180(91)90223-a.
citation: 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.
citation: 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. doi: 10.1532/HSF98.20071082.
citation: 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. doi: 10.1053/j.jvca.2004.11.008.
citation: 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.
citation: 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. No abstract available.
citation: 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. No abstract available.