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

Phase

2/3

Condition

Acute Pain

Cardiac Surgery

Pain

Treatment

N/A

Clinical Study ID

NCT05054179

PIFB Catheter RCT

Ages > 19
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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 partialthromboplastin time (aPTT) exceeding the upper range of normal in the absence ofanticoagulant 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 cathetersecurement
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 GlomerularFiltration Rate (eGFR) < 30 mL/min/1.73 m2)
Known opioid tolerance (as defined by morphine oral equivalent >60mg for a periodof 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., deepbrain stimulation pulse generator or other devices, breast or other implants)

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) > 2mL/kg/hour loss for 2 consecutive hours iv) or requiring return to the operatingroom 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., deepbrain stimulation pulse generator or other devices, breast or other implants)

Study Design

September 07, 2022

July 31, 2024

Study 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:

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.
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.

Connect with a study center

St. Paul's Hospital
Vancouver, British Columbia V6Z 1Y6
Canada
Active - Recruiting

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