Opioid Use Clinical Trial
Official title:
Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) for Patients Undergoing Sternotomy for Congenital Heart Repair
NCT number | NCT03611374 |
Other study ID # | 47032 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 7, 2019 |
Est. completion date | April 6, 2023 |
Verified date | September 2023 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 38 |
Est. completion date | April 6, 2023 |
Est. primary completion date | April 6, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Lucile Packard Children's Hospital Stanford | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
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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. — View 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. — View 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. — View 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. — View Citation
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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. — View 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. — View Citation
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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. — View 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. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Median time to extubation in patients with ESPB | Duration of postoperative recovery (typically 1-2 weeks) | ||
Primary | Median Cardiovascular Intensive Care Unit (CVICU) LOS in patients with ESPB | Duration of postoperative recovery (typically 1-2 weeks) | ||
Primary | Determine average post-operative pain scores in patients with ESPB | Duration of postoperative recovery (typically 1-2 weeks) | ||
Primary | Determine opioid consumption | Duration of postoperative recovery (typically 1-2 weeks) |
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