Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery
Primary Purpose
Coronary Artery Disease, Postoperative Pain, Respiratory Failure
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rectus sheath block with bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring local anesthetic, regional anesthesia, quality of recovery, postoperative pain, coronary artery bypass graft
Eligibility Criteria
Inclusion Criteria:
- Subjects scheduled for cardiac surgery (CABG, CABG + single valve) involving primary median sternotomy and left-sided pleural chest tube
- Age 18-85 years of age
- BMI 18-50 kg/m2
- Weight > 60 kg
Exclusion Criteria:
- Left ventricular ejection fraction (LVEF) < 30%
- Preoperative, intraoperative, or immediate post-operative placement of intra-aortic balloon pump or deployment of extra-corporeal membrane oxygenation (ECMO)
- Inability to understand or speak English
- Allergy to bupivacaine or other amide local anesthetic
- Contraindication to peripheral nerve block (e.g. local infection, previous trauma to the block site)
- Chronic opioid consumption (daily oral morphine equivalent of >20 mg) in the past three months
- Severe pulmonary or hepatic disease
- Neurological deficit or disorder
- Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two years
- Uncontrolled anxiety, schizophrenia, or other severe psychiatric disorder
Sites / Locations
- Medical College of WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rectus sheath block block with PIFB (experimental arm)
Rectus sheath block with PIFB (placebo arm)
Arm Description
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
PIFB with local anesthetic with RSB placebo (saline)
Outcomes
Primary Outcome Measures
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Total cumulative opioid consumption
Total cumulative opioid consumption at 24 hours
Total cumulative opioid consumption
Total cumulative opioid consumption at 48 hours
Secondary Outcome Measures
Intraoperative total opioid consumption
Intraoperative total opioid consumption
Time from ICU arrival to liberation from mechanical ventilation
Time from ICU arrival to liberation from mechanical ventilation
Vital capacity change from baseline on incentive spirometry
Vital capacity change from baseline on incentive spirometry
Vital capacity change from baseline on incentive spirometry
Vital capacity change from baseline on incentive spirometry
Vital capacity change from baseline on incentive spirometry
Vital capacity change from baseline on incentive spirometry
Vital capacity change from baseline on incentive spirometry
Vital capacity change from baseline on incentive spirometry
QoR-15 (Quality of Recovery) score
QoR-15 (Quality of Recovery) score
ICU Length of Stay
ICU Length of Stay
Hospital Length of Stay
Hospital Length of Stay
Full Information
NCT ID
NCT04908449
First Posted
May 24, 2021
Last Updated
August 7, 2023
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT04908449
Brief Title
Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery
Official Title
A Comparison of the Analgesic Effects of Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery: a Prospective, Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with bilateral rectus sheath blocks block decrease pain scores, decrease opioid consumption, improve respiratory function, and improve quality of recovery in patients recovering from elective cardiac surgery involving primary median sternotomy and mediastinal chest tubes in comparison to pectointercostal fascial plane blocks alone.
Detailed Description
This is a single center, prospective, randomized, controlled, double-blinded study. We anticipate recruitment of 50-60 subjects, with 25-30 in each group.
Primary Outcomes:
Pain scores on a 0-10 visual analog scale (VAS) at rest and with deep breathing at 1, 3, 6, 12, 18, and 24 hours post-extubation between subjects receiving PIFB + RSB versus subjects receiving only PIFB.
Total cumulative opioid consumption at 24 and 48 hours post-operatively.
Secondary Outcomes:
Intraoperative total opioid consumption
Change from baseline on incentive spirometry at 1, 3, 12, and 24 hours post-extubation
Time from ICU arrival to liberation from mechanical ventilation
QoR-15 (Quality of Recovery) score23 24 hours after extubation
Hospital and ICU length of stay
Preoperative Management :
Subjects will be randomized on the morning of surgery to receive bilateral PIFB and bilateral RSB with local anesthetic versus bilateral PIFB with local anesthetic and bilateral RSB with saline (placebo).
Intraoperative Management All subjects will receive the standard of care anesthetic regimen for their cardiac surgery.
Postoperative Management Each PIFB will be performed with 15 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine, and bilateral RSB will be performed with an additional 20 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine (10mL on each side).
Postoperative Evaluation:
Evaluation of acute postoperative pain intensity using a 0-10 visual analog scale (VAS) will be undertaken at the following time points, both at rest and with deep breathing:
• 1, 3, 6, 12, 18, and 24 hours post-extubation Incentive spirometry will be assessed at 1, 3, 12, and 24 hours post-extubation, with three measures taken at each time point in order to compare postoperative performance with baseline spirometry.
Review of the medical chart will be made post-operatively to gather other data, including total intraoperative oral morphine equivalent consumption, cumulative opioid consumption at 24 and 48 hours, time from ICU arrival to tracheal extubation, hospital and ICU length of stay, and QoR-15 (Quality of Recovery) score administered 24 hours after extubation (with margin of error of 18-30 hours to avoid waking patients in the middle of the night) . Occurrences of any adverse events reported by the subject or medical team will also be collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Postoperative Pain, Respiratory Failure
Keywords
local anesthetic, regional anesthesia, quality of recovery, postoperative pain, coronary artery bypass graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rectus sheath block block with PIFB (experimental arm)
Arm Type
Experimental
Arm Description
PIFB with local anesthetic with RSB with local anesthetic (bupivacaine)
Arm Title
Rectus sheath block with PIFB (placebo arm)
Arm Type
Placebo Comparator
Arm Description
PIFB with local anesthetic with RSB placebo (saline)
Intervention Type
Drug
Intervention Name(s)
Rectus sheath block with bupivacaine
Other Intervention Name(s)
Rectus sheath block with saline placebo
Intervention Description
Rectus sheath block with local anesthetic versus sham block with saline
Primary Outcome Measure Information:
Title
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Description
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Time Frame
1 hour post-extubation
Title
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Description
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Time Frame
3 hours post-extubation
Title
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Description
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Time Frame
6 hours post-extubation
Title
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Description
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Time Frame
12 hours post-extubation
Title
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Description
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Time Frame
18 hours post-extubation
Title
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Description
Pain scores on a 0-10 visual analog scale at rest and with deep breathing
Time Frame
24 hours post-extubation
Title
Total cumulative opioid consumption
Description
Total cumulative opioid consumption at 24 hours
Time Frame
24 hours post-operatively
Title
Total cumulative opioid consumption
Description
Total cumulative opioid consumption at 48 hours
Time Frame
48 hours post-operatively
Secondary Outcome Measure Information:
Title
Intraoperative total opioid consumption
Description
Intraoperative total opioid consumption
Time Frame
From anesthesia start to anesthesia stop
Title
Time from ICU arrival to liberation from mechanical ventilation
Description
Time from ICU arrival to liberation from mechanical ventilation
Time Frame
ICU arrival until extubation
Title
Vital capacity change from baseline on incentive spirometry
Description
Vital capacity change from baseline on incentive spirometry
Time Frame
1 hour post-extubation
Title
Vital capacity change from baseline on incentive spirometry
Description
Vital capacity change from baseline on incentive spirometry
Time Frame
3 hours post-extubation
Title
Vital capacity change from baseline on incentive spirometry
Description
Vital capacity change from baseline on incentive spirometry
Time Frame
12 hours post-extubation
Title
Vital capacity change from baseline on incentive spirometry
Description
Vital capacity change from baseline on incentive spirometry
Time Frame
24 hours post-extubation
Title
QoR-15 (Quality of Recovery) score
Description
QoR-15 (Quality of Recovery) score
Time Frame
24 hours after extubation
Title
ICU Length of Stay
Description
ICU Length of Stay
Time Frame
Time from anesthesia stop to transfer out of ICU, typically 24 hours
Title
Hospital Length of Stay
Description
Hospital Length of Stay
Time Frame
Time from anesthesia stop to hospital discharge, typically one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects scheduled for cardiac surgery involving primary median sternotomy and mediastinal chest tubes.
Age 18-85 years of age
BMI 18-50 kg/m2
Weight > 60 kg
Exclusion Criteria:
Left ventricular ejection fraction (LVEF) < 30%
Preoperative, intraoperative, or immediate post-operative placement of intra-aortic balloon pump or deployment of extra-corporeal membrane oxygenation (ECMO)
Inability to understand or speak English
Allergy to bupivacaine or other amide local anesthetic
Contraindication to peripheral nerve block (e.g. local infection, previous trauma to the block site)
Chronic opioid consumption (daily oral morphine equivalent of >20 mg) in the past three months
Severe pulmonary or hepatic disease
Neurological deficit or disorder
Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two years
Uncontrolled anxiety, schizophrenia, or other severe psychiatric disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Castro, MD
Phone
414-805-2715
Email
anncastro@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Castro
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne L Castro, MD
Email
anncastro@mcw.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery
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