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Local Anesthetic

PIFB with adjuvants for Pain relief

Phase 4

Waitlist Available

Led By Rawad Hamzi, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 hours after block placement

Awards & highlights

Study Summary

This trial compares post-op pain relief from a nerve block with different solutions. It hypothesizes the best relief comes from the most complex solution.

Eligible Conditions

Pain relief
Sternotomy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours after block placement

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 hours after block placement

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours after block placement for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

AUC Pain Score

Area Under the Curve (AUC) Pain Score

Secondary outcome measures

Average Cumulative Opioid Consumption

Average Time to Extubation

Average Time to First Opioid Administration

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PIFB with adjuvantsExperimental Treatment1 Intervention

Subjects in this arm receive standard of care PIFB with additional medications after surgery

Group II: Pecto-intercostal Fascial Block (PIFB)Active Control1 Intervention

Subjects in this arm receive standard of care PIFB after surgery

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PIFB with adjuvants

2023

Completed Phase 4

~20

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,247 Previous Clinical Trials

1,005,082 Total Patients Enrolled

Rawad Hamzi, MDPrincipal InvestigatorWake Forest University Health Sciences

1 Previous Clinical Trials

154 Total Patients Enrolled

Frequently Asked Questions

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

What are the criteria for potential participants to join this scientific investigation?

"This trial seeks to enroll 20 individuals, aged between 18 and 90 who are suffering from pain. To participate in this study, participants must also be adult patients undergoing a sternotomy cardiac surgery."

Answered by AI

Is the combination of PIFB and adjuvants approved by the Federal Drug Administration?

"Due to the Phase 4 trial status, our team at Power has rated PIFB with adjuvants a 3 on their safety scale. This signifies that this treatment is approved for use in clinical settings."

Answered by AI

Does this trial accept elderly individuals as participants?

"According to the registration requirements, only those aged 18-90 can take part in this study. Subsequently, 80 patients over 65 and 13 under 18 are included in the trial group."

Answered by AI

Are there any available openings in this clinical trial?

"According to the data available on clinicaltrials.gov, this medical study is not presently open for patient recruitment. Initially posted in February 1st 2023 and recently updated in December 22nd 2022, there are 111 alternative trials actively seeking out volunteers at this time."

Answered by AI

What goal is this experimental research seeking to accomplish?

"The goal of this study, which will be assessed during a 6 hour period post-block placement is to assess AUC Pain Score. Secondary metrics include Average Cumulative Opioid Consumption in milligrams; the Average Time to First Opioid Administration taking place after extubation (in minutes); and the Average Time until Extubation (also measured in minutes)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients

2023. "Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05676814.