Coronary Artery DiseasePhase 1NCT04908449
Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery
A Phase 1 study testing Rectus sheath block with bupivacaine in people with Coronary Artery Disease and Postoperative Pain, run by Medical College of Wisconsin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Postoperative Pain, Respiratory Failure
- What is being tested?
- Rectus sheath block with bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2023to 14 Nov 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
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.
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.
Read the detailed description
This is a single center, prospective, randomized, controlled, double-blinded study. We anticipate recruitment of 62 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.
- Being tested
- Rectus sheath block with bupivacaine
- Keywords
- local anesthetic, regional anesthesia, quality of recovery, postoperative pain, coronary artery bypass graft
- Medical subject headings
- Coronary Artery Disease, Pain, Postoperative, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus sheath block with bupivacaineDrug
Also called Rectus sheath block with saline placebo
Rectus sheath block with local anesthetic versus sham block with saline
| Study group | Role | What they receive |
|---|---|---|
| Rectus sheath block block with PIFB (experimental arm) | Experimental | PIFB with local anesthetic with RSB with local anesthetic (bupivacaine) Receives: Drug: Rectus sheath block with bupivacaine |
| Rectus sheath block with PIFB (placebo arm) | Placebo comparator | PIFB with local anesthetic with RSB placebo (saline) Receives: Drug: Rectus sheath block with bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores at Rest Within the First 24 Hours After Extubation
Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score * hours.
Measured: 24 hours after extubation
Pain Scores With Deep Breathing Within the First 24 Hours After Extubation
Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score * hours.
Measured: 24 hours after extubation
Total Cumulative Opioid Consumption
Total cumulative opioid consumption at 24 hours
Measured: 24 hours post-operatively
Total Cumulative Opioid Consumption
Total cumulative opioid consumption at 48 hours
Measured: 48 hours post-operatively
Secondary outcomes (8)
Time From ICU Arrival to Liberation From Mechanical Ventilation
Time from ICU arrival as measured by "anesthesia stop" to liberation from mechanical ventilation (extubation).
Measured: ICU arrival until extubation
Vital Capacity Change From Baseline on Incentive Spirometry
Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).
Measured: 1 hour post-extubation
Vital Capacity Change From Baseline on Incentive Spirometry
Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).
Measured: 3 hours post-extubation
Vital Capacity Change From Baseline on Incentive Spirometry
Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).
Measured: 12 hours post-extubation
Vital Capacity Change From Baseline on Incentive Spirometry
Vital capacity change from baseline on incentive spirometry, measured as a percentage. An incentive spirometer was used to gather vital capacity (measured in mL).
Measured: 24 hours post-extubation
QoR-15 (Quality of Recovery) Score
QoR-15 (Quality of Recovery) score is a 15 question survey asking patients about various aspects of their quality of recovery, including pain control, nausea, anxiety, depression, ability to eat, etc. The scale is 0-150, with higher scores indicating a better outcome.
Measured: 24 hours after extubation
ICU Length of Stay
ICU Length of Stay in hours, as measured by anesthesia stop until transfer out of the ICU.
Measured: Time from anesthesia stop to transfer out of ICU, typically 24 hours
Hospital Length of Stay
Hospital Length of Stay in hours, as measured by anesthesia stop until discharge from the hospital.
Measured: Time from anesthesia stop to hospital discharge, typically one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start19 Jun 2023
- Primary completion8 Nov 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Castro, MD, Medical College of Wisconsin
- Investigators
- Anne Castro, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908449
- Sponsor's protocol ID
- PRO00040365
- Status last verified
- Nov 2025
- First submitted
- 24 May 2021
- Last updated
- 17 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04908449
- Acronym / sponsor ID
- PRO00040365
- Keywords
- local anesthetic, regional anesthesia, quality of recovery, postoperative pain, coronary artery bypass graft
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Posted 17 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 62 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus sheath block block with PIFB (experimental arm) | Experimental | Drug: Rectus sheath block with bupivacainePIFB with local anesthetic with RSB with local anesthetic (bupivacaine) |
| Rectus sheath block with PIFB (placebo arm) | Placebo comparator | Drug: Rectus sheath block with bupivacainePIFB with local anesthetic with RSB placebo (saline) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectus sheath block with bupivacaineAlso: Rectus sheath block with saline placeboRectus sheath block with local anesthetic versus sham block with saline | Drug | Rectus sheath block block with PIFB (experimental arm), Rectus sheath block with PIFB (placebo arm) |
Primary outcome
Pain Scores at Rest Within the First 24 Hours After Extubation
Time frame: 24 hours after extubation
Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score * hours.
Pain Scores With Deep Breathing Within the First 24 Hours After Extubation
Time frame: 24 hours after extubation
Measured by area under the curve (AUC) for pain scores gathered at 1, 3, 6, 12, 18, and 24 hours after extubation. To calculate the Area Under the Curve (AUC) for pain scores, pain intensity is plotted against time and the trapezoidal rule is used to approximate the area under the resulting curve. This AUC value represents the overall pain experience, considering both pain intensity and duration. Scale 0-240, with higher indicating a worse outcome. Units: Numeric rating score * hours.
Total Cumulative Opioid Consumption
Time frame: 24 hours post-operatively
Total cumulative opioid consumption at 24 hours
Total Cumulative Opioid Consumption
Time frame: 48 hours post-operatively
Total cumulative opioid consumption at 48 hours
8 secondary outcomes
Time From ICU Arrival to Liberation From Mechanical Ventilation
Time frame: ICU arrival until extubation
Vital Capacity Change From Baseline on Incentive Spirometry
Time frame: 1 hour post-extubation
Vital Capacity Change From Baseline on Incentive Spirometry
Time frame: 3 hours post-extubation
Vital Capacity Change From Baseline on Incentive Spirometry
Time frame: 12 hours post-extubation
Vital Capacity Change From Baseline on Incentive Spirometry
Time frame: 24 hours post-extubation
QoR-15 (Quality of Recovery) Score
Time frame: 24 hours after extubation
ICU Length of Stay
Time frame: Time from anesthesia stop to transfer out of ICU, typically 24 hours
Hospital Length of Stay
Time frame: Time from anesthesia stop to hospital discharge, typically one week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Castro principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rectus sheath block with bupivacaine in people with Coronary Artery Disease and Postoperative Pain, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores at Rest Within the First 24 Hours After Extubation (time frame: 24 hours after extubation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.