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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral ESP catheter with Lidocaine | Experimental | 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). |
|
| Bilateral ESP catheter with saline | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral ESP catheter with lidocaine | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | IV and PO opioid requirements converted to morphine equivalent | Duration of postoperative recovery (typically 1-2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium and agitation post-operatively | Richmond Agitation-Sedation Score from -5 to +4 (-5 is the most sedation, +4 is the least sedated. | Duration of ICU stay (typically 2-5 days) |
| Determine post-operative pain scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Brodt, MD | Stanford University | Principal Investigator |
| Ban Tsui, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14622770 | Background | Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available. | |
| 23076899 | Background | 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. |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Bilateral ESP catheter with saline | Procedure | 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). |
|
11-point numerical rating scale (NRS) from 0-10, 0 signifying no pain, 10 signifying the worse pain.
| Duration of postoperative recovery (typically 1-2 weeks) |
| Median time to extubation in patients with ESPB | duration in mechanical ventilation in hours | Duration of postoperative recovery (typically 1-2 weeks) |
| Length of stay in hospital | number of post-operative days spent in hospital | Duration of postoperative recovery (typically 1-2 weeks) |
| Length of stay in ICU | number of post-operative days spent in ICU | Duration of postoperative recovery (typically 1-2 weeks) |
| Quality of recovery at 72 hours | 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. | post-operative day 3 |
| Inflammatory biomarker analysis | 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. | First panel pre-incision; second panel 6hrs (+/-3hrs) post-procedure; third panel 24hrs (+/-3hrs) post-procedure; fourth panel 48hrs (+/-3hrs) post-procedure |
| 26440242 | Background | 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. |
| 12842524 | Background | 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. doi: 10.1016/s0003-4975(03)00194-2. |
| 26655308 | Background | 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. |
| 25253674 | Background | 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. |
| 28419054 | Background | 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. No abstract available. |
| 22176767 | Background | 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. |
| 17855198 | Background | 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. |
| 12688271 | Background | Canto M, Sanchez MJ, Casas MA, Bataller ML. Bilateral paravertebral blockade for conventional cardiac surgery. Anaesthesia. 2003 Apr;58(4):365-70. doi: 10.1046/j.1365-2044.2003.03082_2.x. |
| 28592166 | Background | 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. |
| 21239976 | Background | 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. |
| 15747268 | Background | 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. |
| 27501016 | Background | 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. |
| 29649625 | Background | 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. |
| 29631111 | Background | 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. No abstract available. |
| 29684728 | Background | 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. |
| 25886775 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |