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Intercostal Plane Block for Post Cardiac Surgery Pain (EPOCH Trial)

N/A

Recruiting

Led By Ahmad Alli, MD

Research Sponsored by Unity Health Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients undergoing cardiac surgery via median sternotomy

Be older than 18 years old

Must not have

Redo sternotomy, or cardiac surgery performed through non-sternotomy approaches (minimally invasive procedures, thoracotomies, mini-sternotomy, hemi-sternotomy, etc.)

Weight < 50kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 3 months +/- 4 weeks

Summary

This trial will examine if using a block in chest muscles can reduce opioid usage in cardiac surgery patients.

Who is the study for?

This trial is for adults having heart surgery through a cut down the middle of their chest (median sternotomy). It's not for those who've had this type of surgery before, are in unstable condition, weigh less than 50kg, are pregnant or nursing, use opioids long-term or have chronic pain disorders. People with allergies to certain anesthetics or unable to follow the study rules can't join either.

What is being tested?

The trial tests if using intermittent superficial parasternal intercostal plane blocks with ropivacaine reduces opioid need after cardiac surgery compared to placebo (saline). Participants will be randomly assigned to receive either the real block or a sham procedure and monitored for opioid use up to 72 hours post-surgery.

What are the potential side effects?

Possible side effects include reactions at the injection site like pain or infection, potential nerve damage leading to numbness or weakness, allergic reactions to ropivacaine including rash and difficulty breathing, and systemic effects such as low blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult scheduled for heart surgery through a chest bone cut.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had heart surgery either by reopening the chest or through less invasive methods.

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I weigh less than 50kg.

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I am able to understand and follow the study's requirements.

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I have had emergency surgery within the last 2 hours.

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I do not have an active bacterial infection or a pre-existing infection in my chest bone.

Select...

I have had surgery for heart infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 3 months +/- 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at 3 months +/- 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 3 months +/- 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cumulative postoperative opioid use up to 72 hours

Secondary study objectives

Cumulative post-operative opioid use

Delirium

Median pain score

Other study objectives

ICU and hospital length of stay

Post thoracotomy Pain

Postoperative nausea and vomiting

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 0.2% ropivacaineExperimental Treatment1 Intervention

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.

Group II: 0.9% salinePlacebo Group1 Intervention

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.

0 / 7Eligibility criteria met