Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain

NCT05054179 | Unknown Phase 2

• 1 other identifier: PIFB Catheter RCT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

One of the most painful aspects of open heart surgery is the incision made through the skin and the sternum to access the heart (a "sternotomy"). Post-sternotomy pain is a potentially debilitating complication of surgery that slows recovery immediately after surgery and can lead to issues with chronic pain. Previous research has shown that by injecting local anesthesia in the pecto inter-fascial plane, the space between the pectoralis major and the intercostal muscles, pain relief can be provided. The investigators aim to assess if repeated injections of local anesthesia via catheters is a useful adjunct compared to routine care.

Conditions

Cardiac Surgery; Sternotomy; Acute Pain

Keywords

Pecto-intercostal fascial plane catheters; Cardiac surgery; Heart surgery; Sternotomy; Acute pain; Post-sternotomy pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Post-operative Sternal Pain on coughing at 24 hours.

  Cardiac Surgery Intensive Care Unit nurses or recovery ward nurses will assess and record Numeric Rating Scale (NRS) sternal pain scores on coughing. Coughing will be elicited with a standardized script for a sitting patient: "Please use both hands to hold on to the pillow in front of you to hold your chest in. Take a deep breath in, and give me three coughs in a row" The scale is from 0 to 10, with 0 being no pain at all and 10 being the worst pain possible.

  Post-surgery 24 hours after intervention

Secondary Outcomes (7)

• Cumulative opioid consumption (in IV morphine equivalents)

  Post-surgery at 24 and 48 hours after intervention

• Post-operative sternal pain severity

  Post surgery, every 8 hours after intervention up to 48 hours

• Nausea or vomiting

  Post-surgery within 48 hours of intervention

• Quality of Recovery-15 score (QoR-15)

  Pre-surgery (at enrolment) and Post-surgery at 48 hours

• Chronic sternal pain

  Post-surgery at 3 months and 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Drug: Ropivacaine 0.2% Injectable Solution Bolus; Drug: Ropivacaine 0.2% Injectable Solution Infusion

Placebo group

PLACEBO COMPARATOR

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.

Drug: Ropivacaine 0.2% Injectable Solution Bolus; Other: Normal Saline Infusion

Interventions

Ropivacaine 0.2% Injectable Solution Bolus DRUG

20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side

Intervention Group; Placebo group

Normal Saline Infusion OTHER

3 mL/hour infusion of normal saline for 48 hours via parasternal multi-orifice catheters on each side of the sternum

Placebo group

Ropivacaine 0.2% Injectable Solution Infusion DRUG

3 mL/h infusion of Ropivacaine 0.2% for 48 hours via parasternal multi-orifice catheters on each side of the sternum

Intervention Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled cardiac surgery patients
• Complete median sternotomy
• Adult (19 years old or older)
• English-speaking

You may not qualify if:

• Patient refusal
• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Related Publications (25)

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• 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.

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• 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.

  PMID: 20305922 BACKGROUND

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  PMID: 10936130 BACKGROUND

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• 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.

  PMID: 30529177 BACKGROUND

• 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.

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• 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.

  PMID: 31360703 BACKGROUND

• 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.

  PMID: 30902911 BACKGROUND

• 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.

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• 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.

  PMID: 27776104 BACKGROUND

• 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.

  PMID: 28632672 BACKGROUND

• 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.

  PMID: 31300596 BACKGROUND

• 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.

  PMID: 31300594 BACKGROUND

• 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.

  PMID: 28235498 BACKGROUND

• 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.

  PMID: 15616047 BACKGROUND

• 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.

  PMID: 21854260 BACKGROUND

• 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.

  PMID: 17197844 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 30197534 BACKGROUND

• Jen TTH, Prabhakar C, Matras PJ, Rondi K, Bruce S, Sun T, Edwards NY, Mehta S, Schwarz SKW, Chau A, Ree RM. Analgesic efficacy of continuous superficial parasternal intercostal plane blockade in patients undergoing cardiac surgery with median sternotomy: a randomized controlled trial. Reg Anesth Pain Med. 2025 Nov 26:rapm-2025-107162. doi: 10.1136/rapm-2025-107162. Online ahead of print.

  PMID: 41193383 DERIVED

Related Links

• Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) by U.S. Food and Drug Administration

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ron Ree, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Edwards, MHA

CONTACT

778-870-5520; nedwards@providencehealth.bc.ca

Tim TH Jen, MD

CONTACT

tim.jen@ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient Masking: Patients will be informed that they will receive one of two solutions (ropivacaine or saline) for infusion, without disclosing which group they are allocated to. 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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\) 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.

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 23, 2021
• Study Start: September 7, 2022
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)