Regional Anesthesia for Cardiothoracic Enhanced Recovery

NCT03781440 | Unknown

• 1 other identifier: 47647
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Anesthesia, Local; Cardiac Disease; Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  IV and PO opioid requirements converted to morphine equivalent

  Duration of postoperative recovery (typically 1-2 weeks)

Secondary Outcomes (7)

• Delirium and agitation post-operatively

  Duration of ICU stay (typically 2-5 days)

• Determine post-operative pain scores

  Duration of postoperative recovery (typically 1-2 weeks)

• Median time to extubation in patients with ESPB

  Duration of postoperative recovery (typically 1-2 weeks)

• Length of stay in hospital

  Duration of postoperative recovery (typically 1-2 weeks)

• Length of stay in ICU

  Duration of postoperative recovery (typically 1-2 weeks)

Study Arms (2)

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).

Procedure: Bilateral ESP catheter with lidocaine

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).

Procedure: Bilateral ESP catheter with saline

Interventions

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).

Bilateral ESP catheter with Lidocaine

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).

Bilateral ESP catheter with saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (18)

• 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.

  PMID: 14622770 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.

  PMID: 23076899 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.

  PMID: 26440242 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.

  PMID: 12842524 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.

  PMID: 26655308 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.

  PMID: 25253674 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.

  PMID: 28419054 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.

  PMID: 22176767 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.

  PMID: 17855198 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.

  PMID: 12688271 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.

  PMID: 28592166 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.

  PMID: 21239976 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.

  PMID: 15747268 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.

  PMID: 27501016 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.

  PMID: 29649625 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.

  PMID: 29631111 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.

  PMID: 29684728 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.

  PMID: 25886775 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Acute Pain

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jessica Brodt, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Ban Tsui, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 19, 2018
• Study Start: January 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: December 1, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)