Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

Study Overview
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Brief Summary
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The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy. Participants randomized to the intervention group will receive the blocks with 0.2% ropivacaine administered via catheters placed in the superficial parasternal intercostal plane bilaterally under ultrasound guidance. Researchers will compare this group with a control group given 0.9% saline through similarly placed catheters. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.

Detailed Description
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This trial is comparing the use of 0.2% ropivacaine and 0.9% saline through a parasternal intercostal plane block and to measure whether there are any tangible changes in: cumulative postoperative opioid use from catheter insertion until hospital discharge - measured as Milligram Morphine Equivalent (MME) median pain score - measured at rest and with coughing using a standardized numerical rating scale - over 72 hours post catheter insertion delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.

Official Title
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Efficacy of Intermittent Superficial Parasternal Intercostal Plane Block on Postoperative Pain Control in Patients Undergoing Cardiac Surgery With Median Sternotomy - EPOCH Randomized Clinical Trial

Conditions
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Post-operative Pain, Post-operative Delirium, Post-cardiac Surgery, Chronic Pain, Opioid Use Disorder, Anesthesia, Local

Intervention / Treatment
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* Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Experimental
* Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients undergoing cardiac surgery via median sternotomy Exclusion Criteria: Redo sternotomy, or cardiac surgery performed through non-sternotomy approaches (minimally invasive procedures, thoracotomies, mini-sternotomy, hemi-sternotomy, etc.) Emergency procedures (surgery within 2 hours) Clinical instability which in the judgement of the investigator precludes enrollment or participation in the study Weight < 50kg Active systemic bacterial infection including infective endocarditis or pre-existing sternal infections Surgery for infective endocarditis Pregnancy or nursing Chronic opioid/narcotic use > 6 weeks, active use of illicit drugs, long-term opioid exposure or chronic pain disorder/syndromes Allergies to amide anesthetic agents or any components of study interventions Inability to comply with, or participate in, protocol (i.e. cognitive impairment/altered mental status/neurological deficit or disorder, inability to provide informed consent, inability to complete pain rating scales, etc.) Receipt of an investigational drug or device within past 7 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.2% ropivacaine<br>Intermittent superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus dosing of 20 milliliter (mL) of 0.2% ropivacaine per side at the time of catheter placement, followed by intermittent boluses of 10 mL 0.2% ropivacaine per side. | Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Experimental<br>* Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin. Following initial bolus dosing at the time of catheter placement (20 mL 0.2% ropivacaine), intermittent boluses of 10 mL 0.2% ropivacaine per side will be delivered via catheters q6-8 hours for 48 hours post-catheter insertion.<br>|
| Sham Comparator: 0.9% saline<br>Intermitted superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus of 20 mL of 0.9% saline per side at the time of catheter placement, followed by intermitted boluses of 10 ml of 0.9% saline per side. | Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Sham<br>* Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin. Following initial bolus dosing at the time of catheter placement (20 mL 0.9% Saline), intermittent boluses of 10 mL 0.9% Saline per side will be delivered via catheters q6-8 hours for 48 hours post-catheter insertion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative postoperative opioid use up to 72 hours | Postoperative opioid use measured using Milligram Morphine Equivalent | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median pain score | Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse) | over 72 hours post-extubation | 
| Cumulative post-operative opioid use | Measured using Milligram Morphine Equivalent | from time of catheter insertion until discharge from hospital | 
| Delirium | assessed using Confusion Assessment Method (positive or negative; positive indicates delirium present) or Intensive Care Unit Delirium Screen Checklist Score (minimum 0, maximum 8; higher scores is worse; score greater than 3 is positive for delirium) or more than one dose antipsychotic drug or clinical diagnosis by psychiatrist. | for 72 hours following catheter insertion | 
| Quality of Recovery-15 Scale | Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome) | 24-96 hours post surgery |