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PIFB Alone vs. PIFB + RSB for Postoperative Pain

Phase 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up icu arrival until extubation

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours post-extubation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours post-extubation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post-extubation for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Pain scores on a 0-10 visual analog scale at rest and with deep breathing

Total cumulative opioid consumption

Secondary outcome measures

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)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,523 Total Patients Enrolled

2 Trials studying Postoperative Pain

239 Patients Enrolled for Postoperative Pain

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

Postoperative Pain Research Study Groups: Rectus sheath block block with PIFB (experimental arm), Rectus sheath block with PIFB (placebo arm)

Postoperative Pain 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

Frequently Asked Questions

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

What is the scope of participants included in this clinical trial?

"Unfortunately, this medical trial is not accepting new patients. The study was first published on April 1st 2023 and last edited nearly 6 months ago on August 22nd 2022. For those searching for alternative studies related to coronary artery disease, there are currently 1225 trials actively recruiting individuals; similarly, 109 clinical trials concerning Serratus anterior block with bupivacaine are presently enrolling participants."

Answered by AI

What level of risk is associated with administering bupivacaine through a Serratus anterior plane block?

"The limited clinical data available for Serratus anterior plane block with bupivacaine has earned it a score of 1 on our scale. This is because it is presently in its preliminary phase, and there have yet to be multiple rounds of research devoted to the drug's safety or efficacy."

Answered by AI

For what medical conditions is Serratus anterior plane block with bupivacaine a viable treatment option?

"Serratus anterior plane block with bupivacaine can be utilized to treat permphigus, acute nonspecific tenosynovitis, and general anesthesia."

Answered by AI

Who is the optimal candidate for this research endeavor?

"To meet the criteria of this clinical trial, participants must have coronary artery disease and be within a certain age range (18-85). There are 60 spots available in total."

Answered by AI

Is there capacity to enroll additional individuals in this research endeavor?

"This investigation is presently not open for enrollment. It was initially posted on April 1st 2023 with its last update occurring August 22nd 2022. If you are seeking alternative trials, 1225 clinical studies recruiting subjects suffering from coronary artery disease and 109 research initiatives requiring Serratus anterior plane block using bupivacaine currently require participants."

Answered by AI

Could you elucidate other research projects that have explored the use of Serratus anterior plane block with bupivacaine?

"As of now, 109 trials for Serratus anterior plane block with bupivacaine are in operation. 18 of these experiments have progressed to the third stage and 144 research sites across Philadelphia, Pennsylvania alone are conducting clinical trials on this medication."

Answered by AI

Does the minimum age requirement for this medical trial encompass individuals under 50?

"According to the requirements outlined in this trial, only participants between 18 and 85 years of age are eligible. This contrasts with 135 studies that exclusively focus on youth under 18 and 1170 research initiatives tailored for individuals over 65."

Answered by AI

What is the overarching purpose of this research initiative?

"The primary objectives of this medical experiment, which will be evaluated 48 hours after the procedure, are to assess patient pain levels utilizing a 0-10 visual analog scale during rest and deep respiration. Secondary metrics involve an analysis of vital capacity change from baseline via incentive spirometry, time spent in ICU prior to liberation from mechanical ventilation, and Quality Of Recovery score."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery

Anne Castro, MD 2023. "Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04908449.

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