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PIFB Alone vs. PIFB + RSB for Postoperative Pain

Phase 1
Waitlist Available
Led By Anne Castro
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight > 60 kg
Subjects scheduled for cardiac surgery involving primary median sternotomy and mediastinal chest tubes
Must not have
Severe pulmonary or hepatic disease
Inability to understand or speak English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from anesthesia stop to hospital discharge, typically one week

Summary

This trial will compare two types of pain relief after surgery - one with and one without a serratus anterior plane block.

Who is the study for?
This trial is for adults aged 18-85 undergoing elective cardiac surgery with a primary median sternotomy and mediastinal chest tubes. Participants should have a BMI of 18-50 kg/m2, weigh over 60 kg, and understand English. It's not suitable for those with severe heart failure, recent heavy opioid use, certain pre-existing conditions like liver disease or neurological disorders, or allergies to local anesthetics.
What is being tested?
The study tests if combining pectointercostal fascial plane blocks (PIFB) with rectus sheath blocks (RSB), both using bupivacaine, can better manage pain after cardiac surgery compared to PIFB alone. The goal is to see if this approach reduces pain levels, lowers the need for opioids post-surgery, helps breathing recovery and improves overall patient recovery quality.
What are the potential side effects?
Possible side effects include reactions at the injection site such as discomfort or infection; allergic reactions to bupivacaine; potential nerve damage; and systemic effects from the local anesthetic like dizziness, headaches or heart rhythm disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh more than 60 kg.
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I am scheduled for heart surgery that involves opening the front of my chest and placing tubes in the chest area.
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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe lung or liver disease.
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I cannot understand or speak English.
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I do not have uncontrolled severe mental health issues.
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I have had or will have a heart support device placed around my surgery time.
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I have a neurological condition.
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I cannot have a nerve block due to an infection or previous injury at the site.
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I am allergic to bupivacaine or similar pain medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from anesthesia start to anesthesia stop
This trial's timeline: 3 weeks for screening, Varies for treatment, and from anesthesia start to anesthesia stop for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Total cumulative opioid consumption
Secondary study objectives
Hospital Length of Stay
ICU Length of Stay
Intraoperative total opioid consumption
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Rectus sheath block block with PIFB (experimental arm)Experimental Treatment1 Intervention
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Group II: Rectus sheath block with PIFB (placebo arm)Placebo Group1 Intervention
PIFB with local anesthetic with RSB placebo (saline)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rectus sheath block with bupivacaine
2023
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
631 Previous Clinical Trials
1,181,896 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
308 Patients Enrolled for Coronary Artery Disease
Anne CastroPrincipal InvestigatorMedical College of Wisconsin

Media Library

Rectus sheath block block with PIFB (experimental arm) Clinical Trial Eligibility Overview. Trial Name: NCT04908449 — Phase 1
Coronary Artery Disease Research Study Groups: Rectus sheath block block with PIFB (experimental arm), Rectus sheath block with PIFB (placebo arm)
Coronary Artery Disease Clinical Trial 2023: Rectus sheath block block with PIFB (experimental arm) Highlights & Side Effects. Trial Name: NCT04908449 — Phase 1
Rectus sheath block block with PIFB (experimental arm) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04908449 — Phase 1
~26 spots leftby Dec 2025
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