Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain
NCT ID: NCT05054179
Last Updated: 2022-11-04
Study Results
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Basic Information
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UNKNOWN
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2022-09-07
2024-07-31
Brief Summary
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Detailed Description
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Post-sternotomy pain after cardiac surgery can be debilitating, with associated risks of decreased respiratory function and chronic pain. Severe acute sternal pain after cardiac surgery occurs in 49% of patients at rest and 78% of patients during coughing. Post-sternotomy pain is worst during the first two days and improves thereafter.
The sternum is innervated by the medial division of the anterior cutaneous branches of the T2-6 intercostal nerves, which may be targeted by several regional anesthetic techniques. Concerns of rare epidural hematoma and possible case cancellations with a bloody tap, in the context of systemic heparinization for cardiac surgery, deters many from utilizing neuraxial analgesia for post-sternotomy pain. Contrarily, parasternal regional blocks such as pecto-intercostal fascial plane block (PIFB) provide a low-risk alternative that targets the anterior cutaneous branches of intercostal nerves, and PIFB has been shown to be effective in improving acute post-sternotomy pain.
Nevertheless, single-shot PIFB is limited by its short duration of action, whereas sternotomy pain can remain severe for two postoperative days. Hence, continuous local anesthetic infusion via bilateral PIFB catheters for 48 hours may improve patient pain experience and related outcomes over single shot PIFB.
Objective:
This study aims to evaluate whether, in addition to single shot PIFB, continuous local anesthetic infusion (compared with placebo infusion) through bilateral PIFB catheters reduces acute sternal pain at 24 hours after cardiac surgery with complete median sternotomy. The 24-hour time point was chosen as it represents a time where both the post-sternotomy pain is rated as severe, especially with movement and coughing, and the patient is required to start actively participating in the postoperative rehabilitative process.
Hypotheses:
This study hypothesize that, in addition to single shot PIFB, continuous ropivacaine infusion through bilateral PIFB catheters will be more effective than placebo infusion in reducing sternal pain score on standardized coughing at 24 hours after cardiac surgery with complete median sternotomy.
Study Design:
This will be a prospective, randomized, triple-blinded, placebo-controlled trial in which patients will be randomly allocated to two study groups on a 1:1 basis into:
1\) Treatment Group: 20 mL of ropivacaine 0.2% will be deposited via parasternal multi-orifice catheters on each side, followed by infusion of 3 mL/h for 48 hours.
2\) Control Group: 20 mL of ropivacaine 0.2% will be deposited via parasternal multi-orifice catheters on each side, followed by a saline infusion of 3 mL/h for 48 hours.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1\) Intervention Group: 20 mL of ropivacaine 0.2% will be bolused through PIFB catheters on each side, followed by 3 mL/hour infusion of ropivacaine 0.2% for 48 hours each side.
2\) Control Group: 20 mL of ropivacaine 0.2% will be bolused through PIFB catheters on each side, followed by 3 mL/hour infusion of normal saline for 48 hours each side.
SUPPORTIVE_CARE
QUADRUPLE
Anesthesiologists, cardiac surgeons, Cardiac Surgery Intensive Care Unit (CSICU) nurses, ward nurses, nurse practitioners, and acute pain service team Masking: blinded/masked to assignments.
Assessors Masking: Assessment of patients, data collection, and follow-up will be conducted by team members (i.e. research assistant, anesthesiologist, CSICU nurses, and ward nurses, acute pain service team) will be blinded/masked to group allocation of a patient participant.
Data Analyst Masking: The data analysts will be provided a table with two groups of the unique numbers, but which group corresponds with ropivacaine and which corresponds with normal saline will not be revealed until the data analysis has been fully completed.
Study Groups
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Intervention Group
The participants of this group will receive 20 mL of 0.2% Ropivacaine via parasternal multi-orifice catheters on each side of the sternum, followed by infusion of 3 mL/h for 48 hours.
Ropivacaine 0.2% Injectable Solution Bolus
20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side
Ropivacaine 0.2% Injectable Solution Infusion
3 mL/h infusion of Ropivacaine 0.2% for 48 hours via parasternal multi-orifice catheters on each side of the sternum
Placebo group
The participants of this group will receive 20 mL of 0.2% Ropivacaine via parasternal multi-orifice catheters on each side of the sternum, followed by infusion of 3 mL/h of normal saline for 48 hours.
Ropivacaine 0.2% Injectable Solution Bolus
20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side
Normal Saline Infusion
3 mL/hour infusion of normal saline for 48 hours via parasternal multi-orifice catheters on each side of the sternum
Interventions
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Ropivacaine 0.2% Injectable Solution Bolus
20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side
Normal Saline Infusion
3 mL/hour infusion of normal saline for 48 hours via parasternal multi-orifice catheters on each side of the sternum
Ropivacaine 0.2% Injectable Solution Infusion
3 mL/h infusion of Ropivacaine 0.2% for 48 hours via parasternal multi-orifice catheters on each side of the sternum
Eligibility Criteria
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Inclusion Criteria
* Complete median sternotomy
* Adult (19 years old or older)
* English-speaking
Exclusion Criteria
* Emergent surgery
* Inability to provide consent
* Expected inability to follow up via telephone
* Known preoperative coagulopathy
i) Congenital coagulopathy ii) Congenital platelet disorders iii) Platelet count \< 50 x 10\^9 iv) International normalized ratio (INR) or activated partial thromboplastin time (aPTT) exceeding the upper range of normal in the absence of anticoagulant use v) Does not include active anticoagulant or antiplatelet use
* Known predicted post-operative therapeutic anticoagulation within 48 hours.
* Known skin disease over block insertion site that would prevent catheter securement
* Known Immunodeficiency including uncontrolled diabetes, as defined by HbA1C of 7.8% or more
* Known preoperative advanced liver failure (as defined by Child-Pugh B or C)
* Known preoperative advanced renal failure (as defined by Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m2)
* Known opioid tolerance (as defined by morphine oral equivalent \>60mg for a period of 7 days or longer pre-operatively)
* Known allergy to local anesthetic, acetaminophen, or hydromorphone
* Known weight less than 60 kg
* Any known technical or physical barrier to block catheter placement (i.e., deep brain stimulation pulse generator or other devices, breast or other implants)
* Postoperative bleeding at time of randomization as defined by:
i) initial chest tube loss of \>350 mL ii) \>200 mL per hour loss iii) \> 2 mL/kg/hour loss for 2 consecutive hours iv) or requiring return to the operating room for surgical management
* Hemodynamic instability, as determined by Cardiac Surgery Intensive Care Unit (CSICU) attending anesthesiologist
* Anticipated mechanical ventilation of more than 24 hours
* Anesthesiologist unavailable to insert Pecto-Intercostal Fascial Plane Block (PIFB) catheter within 4 hours of CSICU arrival
* Any known technical or physical barrier to block catheter placement (i.e., deep brain stimulation pulse generator or other devices, breast or other implants)
19 Years
ALL
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Ron Ree
Clinical Associate Professor
Principal Investigators
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Ron Ree, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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St. Paul's Hospital
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Liu V, Mariano ER, Prabhakar C. Pecto-intercostal Fascial Block for Acute Poststernotomy Pain: A Case Report. A A Pract. 2018 Jun 15;10(12):319-322. doi: 10.1213/XAA.0000000000000697.
Lee W, Yan YY, Jensen MP, Shun SC, Lin YK, Tsai TP, Lai YH. Predictors and patterns of chronic pain three months after cardiac surgery in Taiwan. Pain Med. 2010 Dec;11(12):1849-58. doi: 10.1111/j.1526-4637.2010.00976.x. Epub 2010 Oct 28.
van Gulik L, Janssen LI, Ahlers SJ, Bruins P, Driessen AH, van Boven WJ, van Dongen EP, Knibbe CA. Risk factors for chronic thoracic pain after cardiac surgery via sternotomy. Eur J Cardiothorac Surg. 2011 Dec;40(6):1309-13. doi: 10.1016/j.ejcts.2011.03.039. Epub 2011 May 10.
Gust R, Pecher S, Gust A, Hoffmann V, Bohrer H, Martin E. Effect of patient-controlled analgesia on pulmonary complications after coronary artery bypass grafting. Crit Care Med. 1999 Oct;27(10):2218-23. doi: 10.1097/00003246-199910000-00025.
Sasseron AB, Figueiredo LC, Trova K, Cardoso AL, Lima NM, Olmos SC, Petrucci O. Does the pain disturb the respiratory function after open heart surgery? Rev Bras Cir Cardiovasc. 2009 Oct-Dec;24(4):490-6. doi: 10.1590/s0102-76382009000500010. English, Portuguese.
Mueller XM, Tinguely F, Tevaearai HT, Revelly JP, Chiolero R, von Segesser LK. Pain location, distribution, and intensity after cardiac surgery. Chest. 2000 Aug;118(2):391-6. doi: 10.1378/chest.118.2.391.
Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.
Milgrom LB, Brooks JA, Qi R, Bunnell K, Wuestfeld S, Beckman D. Pain levels experienced with activities after cardiac surgery. Am J Crit Care. 2004 Mar;13(2):116-25.
Mittnacht AJC, Shariat A, Weiner MM, Malhotra A, Miller MA, Mahajan A, Bhatt HV. Regional Techniques for Cardiac and Cardiac-Related Procedures. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):532-546. doi: 10.1053/j.jvca.2018.09.017. Epub 2018 Sep 13. No abstract available.
Hemmerling TM, Cyr S, Terrasini N. Epidural catheterization in cardiac surgery: the 2012 risk assessment. Ann Card Anaesth. 2013 Jul-Sep;16(3):169-77. doi: 10.4103/0971-9784.114237.
Fujii S, Bairagi R, Roche M, Zhou JR. Transversus Thoracis Muscle Plane Block. Biomed Res Int. 2019 Jul 7;2019:1716365. doi: 10.1155/2019/1716365. eCollection 2019.
Fujii S, Roche M, Jones PM, Vissa D, Bainbridge D, Zhou JR. Transversus thoracis muscle plane block in cardiac surgery: a pilot feasibility study. Reg Anesth Pain Med. 2019 May;44(5):556-560. doi: 10.1136/rapm-2018-100178. Epub 2019 Mar 21.
Chin KJ. An Anatomical Basis for Naming Plane Blocks of the Anteromedial Chest Wall. Reg Anesth Pain Med. 2017 May/Jun;42(3):414-415. doi: 10.1097/AAP.0000000000000575. No abstract available.
Murata H, Hida K, Hara T. Reply to Dr Del Buono et al. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):792. doi: 10.1097/AAP.0000000000000491. No abstract available.
Fujii S, Vissa D, Ganapathy S, Johnson M, Zhou J. Transversus Thoracic Muscle Plane Block on a Cadaver With History of Coronary Artery Bypass Grafting. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):535-537. doi: 10.1097/AAP.0000000000000607. No abstract available.
Garcia Simon D, Fajardo Perez M. Safer alternatives to transversus thoracis muscle plane block. Reg Anesth Pain Med. 2019 Jul 11:rapm-2019-100666. doi: 10.1136/rapm-2019-100666. Online ahead of print. No abstract available.
Fujii S. Transversus thoracis muscle plane block and alternative techniques. Reg Anesth Pain Med. 2019 Jul 11:rapm-2019-100755. doi: 10.1136/rapm-2019-100755. Online ahead of print. No abstract available.
Ueshima H, Otake H. RETRACTED: Optimal site for the subpectoral interfascial plane block. J Clin Anesth. 2017 Feb;37:115. doi: 10.1016/j.jclinane.2016.12.022. Epub 2017 Jan 9. No abstract available.
McDonald SB, Jacobsohn E, Kopacz DJ, Desphande S, Helman JD, Salinas F, Hall RA. Parasternal block and local anesthetic infiltration with levobupivacaine after cardiac surgery with desflurane: the effect on postoperative pain, pulmonary function, and tracheal extubation times. Anesth Analg. 2005 Jan;100(1):25-32. doi: 10.1213/01.ANE.0000139652.84897.BD.
Gianchandani RY, Saberi S, Zrull CA, Patil PV, Jha L, Kling-Colson SC, Gandia KG, DuBois EC, Plunkett CD, Bodnar TW, Pop-Busui R. Evaluation of hemoglobin A1c criteria to assess preoperative diabetes risk in cardiac surgery patients. Diabetes Technol Ther. 2011 Dec;13(12):1249-54. doi: 10.1089/dia.2011.0074. Epub 2011 Aug 21.
Jokinen MJ, Neuvonen PJ, Lindgren L, Hockerstedt K, Sjovall J, Breuer O, Askemark Y, Ahonen J, Olkkola KT. Pharmacokinetics of ropivacaine in patients with chronic end-stage liver disease. Anesthesiology. 2007 Jan;106(1):43-55. doi: 10.1097/00000542-200701000-00011.
Christensen MC, Dziewior F, Kempel A, von Heymann C. Increased chest tube drainage is independently associated with adverse outcome after cardiac surgery. J Cardiothorac Vasc Anesth. 2012 Feb;26(1):46-51. doi: 10.1053/j.jvca.2011.09.021. Epub 2011 Nov 18.
Bernstein SL, Bijur PE, Gallagher EJ. Relationship between intensity and relief in patients with acute severe pain. Am J Emerg Med. 2006 Mar;24(2):162-6. doi: 10.1016/j.ajem.2005.08.007.
Zubrzycki M, Liebold A, Skrabal C, Reinelt H, Ziegler M, Perdas E, Zubrzycka M. Assessment and pathophysiology of pain in cardiac surgery. J Pain Res. 2018 Aug 24;11:1599-1611. doi: 10.2147/JPR.S162067. eCollection 2018.
Provided Documents
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Document Type: Study Protocol
Related Links
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Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) by U.S. Food and Drug Administration
Other Identifiers
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PIFB Catheter RCT
Identifier Type: -
Identifier Source: org_study_id
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