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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 3 months +/- 4 weeks

Awards & highlights

EPOCH Trial 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.Check my eligibility

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.See study design

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.

EPOCH Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

EPOCH Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cumulative postoperative opioid use up to 72 hours

Secondary outcome measures

Cumulative post-operative opioid use

Delirium

Median pain score

Other outcome measures

ICU and hospital length of stay

Post thoracotomy Pain

Postoperative nausea and vomiting

+4 more

EPOCH 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor

540 Previous Clinical Trials

447,470 Total Patients Enrolled

1 Trials studying Delirium

550 Patients Enrolled for Delirium

Ahmad Alli, MDPrincipal InvestigatorUnity Health Toronto

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment quota for this clinical trial?

"Affirmative. As per the information present on clinicaltrials.gov, this research trial is currently soliciting volunteers. This study was initially posted on September 1st 2023 and its latest update occurred 13 days later. The team needs to recruit 310 people from a single site."

Answered by AI

Is this analysis currently recruiting participants?

"Affirmative. Clinicaltrials.gov data confirms that this investigation, which was first published on September 1st 2023, is presently enrolling patients. The study is hoping to recruit 310 individuals across one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

Ahmad Alli 2023. "Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06028126.