Back to resultsPecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
Primary Purpose
Analgesia, Sternotomy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pecto-intercostal Fascial Block (PIFB)
PIFB with adjuvants
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia focused on measuring Pecto-intercostal Fascial Block, Postoperative, Pain, Cardiac Surgery
Eligibility Criteria
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
Sites / Locations
- Wake Forest Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Pecto-intercostal Fascial Block (PIFB)
PIFB with adjuvants
Arm Description
Subjects in this arm receive standard of care PIFB after surgery
Subjects in this arm receive standard of care PIFB with additional medications after surgery
Outcomes
Primary Outcome Measures
Area Under the Curve (AUC) Pain Score
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.
AUC Pain Score
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.
AUC Pain Score
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.
AUC Pain Score
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.
AUC Pain Score
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.
Secondary Outcome Measures
Patient-reported NRS Pain Scores at Rest
Pain scores range from 0 to 10 with higher scores denoting more pain.
Patient-reported NRS Pain Scores at Rest
Pain scores range from 0 to 10 with higher scores denoting more pain.
Average Cumulative Opioid Consumption
In milligrams
Average Time to First Opioid Administration
Postoperative after extubation in minutes
Average Time to Extubation
In minutes
Duration of Intensive Care Unit (ICU) Admission
Average number of hours
Incentive Spirometry Volumes
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.
Safety Outcome: Nausea Incidence
Average number of incidences
Safety Outcome: Vomiting Incidence
Average number of incidences
Safety Outcome: Postoperative Delirium Incidence
Average number of incidences
NRS Satisfaction with the Analgesic Regimen
Patient-reported scores range from 0-10 where 0 represents completely unsatisfied and 10 represents completely satisfied.
Full Information
NCT ID
NCT05676814
First Posted
December 22, 2022
Last Updated
September 7, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05676814
Brief Title
Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
Official Title
Pecto-intercostal Fascial Block With Perineural Adjuvants for Postoperative Analgesia Following Sternotomy in Patients Undergoing Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 24, 2023 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
June 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Sternotomy
Keywords
Pecto-intercostal Fascial Block, Postoperative, Pain, Cardiac Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients will be blinded to their treatment arm assignment, as will all research personnel who be responsible for collection of outcome data, as well as the surgeons performing the procedure, and critical care staff caring for the patients in the postoperative period. The anesthesiologist who will be performing the Pecto-intercostal Fascial Block (PIFB) will open the envelope informing them of the arm assignment; they will be the only care providers unblinded.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pecto-intercostal Fascial Block (PIFB)
Arm Type
Active Comparator
Arm Description
Subjects in this arm receive standard of care PIFB after surgery
Arm Title
PIFB with adjuvants
Arm Type
Experimental
Arm Description
Subjects in this arm receive standard of care PIFB with additional medications after surgery
Intervention Type
Drug
Intervention Name(s)
Pecto-intercostal Fascial Block (PIFB)
Intervention Description
PIFB done with bupivacaine and epinephrine
Intervention Type
Drug
Intervention Name(s)
PIFB with adjuvants
Intervention Description
PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC) Pain Score
Description
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.
Time Frame
6 hours after block placement
Title
AUC Pain Score
Description
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.
Time Frame
12 hours after block placement
Title
AUC Pain Score
Description
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.
Time Frame
18 hours after block placement
Title
AUC Pain Score
Description
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.
Time Frame
24 hours after block placement
Title
AUC Pain Score
Description
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.
Time Frame
36 hours after block placement
Secondary Outcome Measure Information:
Title
Patient-reported NRS Pain Scores at Rest
Description
Pain scores range from 0 to 10 with higher scores denoting more pain.
Time Frame
6 hours after block placement
Title
Patient-reported NRS Pain Scores at Rest
Description
Pain scores range from 0 to 10 with higher scores denoting more pain.
Time Frame
6, 12, 18, 24, and 36 hours after block placement
Title
Average Cumulative Opioid Consumption
Description
In milligrams
Time Frame
36 hours after block placement
Title
Average Time to First Opioid Administration
Description
Postoperative after extubation in minutes
Time Frame
Up to 36 hours after block placement
Title
Average Time to Extubation
Description
In minutes
Time Frame
Up to 36 hours after block placement
Title
Duration of Intensive Care Unit (ICU) Admission
Description
Average number of hours
Time Frame
Up to 36 hours after block placement
Title
Incentive Spirometry Volumes
Description
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.
Time Frame
6, 12, 18, 24, and 36 hours after block placement
Title
Safety Outcome: Nausea Incidence
Description
Average number of incidences
Time Frame
Up to 36 hours after block placement
Title
Safety Outcome: Vomiting Incidence
Description
Average number of incidences
Time Frame
Up to 36 hours after block placement
Title
Safety Outcome: Postoperative Delirium Incidence
Description
Average number of incidences
Time Frame
Up to 36 hours after block placement
Title
NRS Satisfaction with the Analgesic Regimen
Description
Patient-reported scores range from 0-10 where 0 represents completely unsatisfied and 10 represents completely satisfied.
Time Frame
36 hours after block placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rawad Hamzi, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
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