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

NCT05676814 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-06-11

Study results available
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Summary

The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.

Conditions

  • Analgesia
  • Sternotomy

Interventions

DRUG

Pecto-intercostal Fascial Block (PIFB)

PIFB done with bupivacaine and epinephrine

DRUG

PIFB with adjuvants

PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Scott Coleman, DO · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2023-06-23
Completion
2023-06-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05676814 on ClinicalTrials.gov