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Nerve Blocks for Post-Surgical Pain After Cardiac Surgery

Phase < 1

Waitlist Available

Led By Ali Shariat, M.D.

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Adults 18-85 years old

Scheduled to undergo cardiac procedures involving sternotomy

Must not have

Urgent or emergent surgery

Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative 72 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two nerve blocks to reduce post-surgical pain in 90 people aged 18-85 undergoing cardiac surgery. Pain scores & opioid consumption will be monitored. Risks include nervous & cardiac system toxicity.

Who is the study for?

This trial is for adults aged 18-85 who are scheduled for cardiac surgery involving a sternotomy. It's open to all genders. People can't join if they're in critical health (ASA class V), need urgent surgery, have allergies to local anesthesia, can't consent, or have a history of substance abuse or chronic opioid use.

What is being tested?

The study compares the effectiveness of two pain control methods after heart surgery: ESP block and PIF block using ultrasound guidance and Bupivacain. Participants will be randomly assigned one of three different regimens at the start of their surgery.

What are the potential side effects?

While side effects are not common, there's a risk that the local anesthetic could get absorbed into the body causing potential toxicity which might affect both the brain and heart.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 85 years old.

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I am scheduled for heart surgery that involves opening my chest.

Exclusion Criteria

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

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I need surgery urgently or as an emergency.

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I am allergic to or cannot have local anesthesia.

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I am unable or unwilling to give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative 72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative 72 hours for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Opioid Consumption during first 24 hours post-op

Opioid Consumption during first 48 hours post-op

Opioid Consumption during first 72 hours post-op

Secondary study objectives

Visual Analogue Score (VAS) Pain Score post-op 24 hours

Visual Analogue Score (VAS) Pain Score post-op 48 hours

Visual Analogue Score (VAS) Pain Score post-op 72 hours

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: PIF groupExperimental Treatment3 Interventions

Patient will receive PIF block after intubation with ultrasound placed 1-2 cm lateral to the sternal border and the pectoralis major and external intercostal muscles are visualized at the level of ribs 3-4 where 10 mL of 0.25% bupivacaine will be injected on each side using a 21-gauge block needle.

Group II: ESP groupExperimental Treatment3 Interventions

Patient will receive ESP block with ultrasound guidance the transverse process of the vertebra at T7 is visualized and 20 mL of 0.25% bupivacaine will be injected between the transverse process and the erector spinae muscle on each side using a 21-gauge block needle.

Group III: No Block groupActive Control1 Intervention

Patient will not receive block.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ESP block

2019

Completed Phase 4

~760

Ultrasound

2013