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

May 13, 2024 updated by: Wake Forest University Health Sciences

Pecto-intercostal Fascial Block With Perineural Adjuvants for Postoperative Analgesia Following Sternotomy in Patients Undergoing Cardiac Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a randomized, triple-blinded, prospective, feasibility trial. Written informed consent will be obtained from all study participants prior to randomization. Patients scheduled to undergo cardiac surgery involving sternotomy at Atrium Health Wake Forest Baptist will be screened for eligibility. These patients will be approached for enrollment by research staff either during their preoperative assessment clinic visit prior to their surgery date, or when admitted as inpatients and scheduled for surgery. Subjects chosen to participate will be randomized into one or other arm and PIFB will be performed after skin closure and before transport from the operating room to the ICU. For patients who are randomized at enrollment but later excluded due to exclusion criteria prior to block placement, their randomization assignment will be replaced at the end of the initial recruitment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults between undergoing cardiac surgery involving sternotomy

Exclusion Criteria:

  • Patients with any contraindications to regional anesthesia, such as history of allergy to amide local anesthetics or any of the perineural adjuvants
  • existing neurologic deficit in the chest wall;
  • remaining intubated at the six hour point after block placement
  • weight under 50kg
  • undergoing emergency surgical procedures or urgent return to the operating room
  • active endocarditis or mediastinitis
  • moderate to severe right ventricular function before or after cardiopulmonary bypass
  • reliance on mechanical circulatory support devices, such as intra-aortic balloon pump or Impella
  • reliance on extracorporeal membrane oxygenation
  • localized or systemic infection
  • chronic use of high dose opioid analgesics (defined as daily use greater than 30 oral morphine milligram equivalents (OMME) for over one month prior to surgery)
  • those who are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Pecto-intercostal Fascial Block (PIFB)
Subjects in this arm receive standard of care PIFB after surgery
Drug: Pecto-intercostal Fascial Block (PIFB)
PIFB done with bupivacaine and epinephrine
Experimental: PIFB with adjuvants
Subjects in this arm receive standard of care PIFB with additional medications after surgery
Drug: PIFB with adjuvants
PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Time Frame: 0 to 6 hours after block placement
Based on patient-reported dynamic Numerical Rating Scale (NRS) pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. 0 to 6 hrs after placement.
0 to 6 hours after block placement
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Time Frame: 12 hours after block placement
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
12 hours after block placement
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Time Frame: 18 hours after block placement
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
18 hours after block placement
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Time Frame: 24 hours after block placement
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
24 hours after block placement
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Time Frame: 36 hours after block placement
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
36 hours after block placement

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
Time Frame: 6 hours after block placement
Pain scores range from 0 to 10 with higher scores denoting more pain.
6 hours after block placement
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
Time Frame: 6, 12, 18, 24 hours after block placement
Pain scores range from 0 to 10 with higher scores denoting more pain.
6, 12, 18, 24 hours after block placement
Average Cumulative Opioid Consumption
Time Frame: 36 hours after block placement
Average Cumulative Opioid Consumption in milligrams
36 hours after block placement
Average Time to First Opioid Administration
Time Frame: Up to 36 hours after block placement
Average Time to First Opioid Administration - Postoperative after extubation measured in minutes
Up to 36 hours after block placement
Average Time to Extubation
Time Frame: Up to 36 hours after block placement
Average Time to Extubation - measured in minutes
Up to 36 hours after block placement
Duration of Intensive Care Unit (ICU) Admission
Time Frame: Up to 52 hours after block placement
Duration of Intensive Care Unit (ICU) Admission - measured in Average number of hours.
Up to 52 hours after block placement
Incentive Spirometry Volumes
Time Frame: 6, 12, 18, 24 hours after block placement
An incentive spirometer is a handheld medical device that measures the volume of subject's breath. The volume of air displaced is indicated in milliliters on a scale located on the device enclosure. This device measures what is called vital capacity, the amount of air that is breathed in and out of the lungs.
6, 12, 18, 24 hours after block placement
Safety Outcome: Nausea Incidence
Time Frame: Up to 36 hours after block placement
Average number of incidences of Nausea
Up to 36 hours after block placement
Safety Outcome: Vomiting Incidence
Time Frame: Up to 36 hours after block placement
Average number of Vomiting incidences
Up to 36 hours after block placement
Safety Outcome: Postoperative Delirium Incidence
Time Frame: Up to 36 hours after block placement
Average number of Delirium incidences
Up to 36 hours after block placement
Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen
Time Frame: 36 hours after block placement
Patient-reported scores range from 0-10 where 0 represents completely unsatisfied and 10 represents completely satisfied.
36 hours after block placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott Coleman, DO, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00090669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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