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

Acute Pain Clinical Trial

Official title:

The Efficacy of Pecto-intercostal Fascial Plane Catheters for Reduction of Sternal Pain in Cardiac Surgery Patients With Complete Median Sternotomy: A Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05054179
• Other study ID #: PIFB Catheter RCT
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 7, 2022
• Est. completion date: July 2024

Study information

• Verified date: November 2022
• Source: University of British Columbia
• Contact: Nicola Edwards, MHA
• Phone: 778-870-5520
• Email: nedwards[@]providencehealth.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Justification: 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Preoperative Exclusion Criteria:

• 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)

2. Postoperative Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Acute Pain
• Cardiac Surgery
• Sternotomy

Intervention

Drug:
• Ropivacaine 0.2% Injectable Solution Bolus
20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side

Other:
• Normal Saline Infusion
3 mL/hour infusion of normal saline for 48 hours via parasternal multi-orifice catheters on each side of the sternum

Drug:
• 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

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (24)

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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. Review. — View Citation

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Jokinen MJ, Neuvonen PJ, Lindgren L, Höckerstedt K, Sjövall 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. — View Citation

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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. — View Citation

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. — View Citation

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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. Retraction in: J Clin Anesth. 2022 Aug;79:110774. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cumulative opioid consumption (in IV morphine equivalents)	After patient's discharge from hospital, medical record will be reviewed for opioid (in IV morphine equivalents) consumption history.	Post-surgery at 24 and 48 hours after intervention
Secondary	Post-operative sternal pain severity	Cardiac Surgery Intensive Care Unit nurses or recovery ward nurses will assess and record Numeric Rating Scale (NRS) sternal pain scores at rest and on coughing up to 48 hours after the intervention.; 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.; These scores will be recorded every 8 hours.	Post surgery, every 8 hours after intervention up to 48 hours
Secondary	Nausea or vomiting	After patient's discharge from hospital, medical record will be reviewed for nausea or vomiting and reported as yes or no.	Post-surgery within 48 hours of intervention
Secondary	Quality of Recovery-15 score (QoR-15)	The research assistant/research coordinator will administer Quality of Recovery-15 score (QoR-15). The QoR-15 includes Part A and Part B. Part A consists of 10 questions regarding how the patient has been feeling in the last 24 hours on a 11-point likert scale from 0 to 10, with 0 being "None of the time" and 10 being "All of the time". Part B consists of 5 questions regarding if the patient has had any of the following in the last 24 hours on the same scale as Part A.	Pre-surgery (at enrolment) and Post-surgery at 48 hours
Secondary	Chronic sternal pain	After patient's discharge from hospital, they will be called at 3 months and 6 months post-surgery and asked about their sternal pain severity on a numeric rating scale of 0-10.	Post-surgery at 3 months and 6 months
Secondary	Quality of Life Questionnaire	Participants will complete a quality of life questionnaire, the EQ-5D-5L, preoperatively, at 48 hours, 3 months and 6 months. The first two assessments will be done in person, the 3 and 6 month follow-ups will be done over the phone. The questionnaire consists of 5 dimensions of life (Mobility, Self-Care, Usual Activities, Pain and Discomfort, and Anxiety/Depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Pre-operatively (at enrolment), 48 hours after intervention and 3 and 6 months after discharge from hospital
Secondary	Overall Health (EQ-5D VAS)	Participants will report their overall health rating using the EQ-5D Visual Analog Scale (0-100, with 0 being the worst health you can imagine and 100 being the best health you can imagine). This is done preoperatively, at 48 hours, 3 months and 6 months. The first two assessments will be done in person, the 3 and 6 month follow-ups will be done over the phone.	Pre-operatively (at enrolment), 48 hours after intervention and 3 and 6 months after discharge from hospital

External Links

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