Cardiac SurgeryPhase 4NCT04928339
Pecto-Intercostal Fascial Plane Block Study
A Phase 4 study testing Bupivacaine Injection, Liposomal bupivacaine and Saline in people with Cardiac Surgery and Opioid Use, Unspecified, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery, Opioid Use, Unspecified
- What is being tested?
- Bupivacaine Injection, Liposomal bupivacaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 30 Nov 2023
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant provides consent to participate in study
- Ideal body weight (IBW) is >50kg
- Participant is planned to undergo coronary artery bypass graft or single valve repair/replacement surgery via median sternotomy
- Participant is undergoing an elective procedure
Who cannot join
- Participant is unable or unwilling to give consent
- Non-English speaking
- Known or believed to be pregnant or is currently breastfeeding
- Participant is a prisoner
- Clinically unstable per discretion of the Investigator
- Participant requires urgent/emergent surgery
Show all 14Show fewer
- History of previous sternotomy
- Preoperative coagulopathy (INR >1.4, platelets <100,000) or ongoing anticoagulation or anti-platelet therapy (except aspirin 81mg)
- Allergy or sensitivity to amide-type local anesthetics, dexmedetomidine or ketamine
- Participant has decompensated heart failure
- Severe left ventricle dysfunction (defined quantitatively as an ejection fraction of less than or equal to 35%) or right ventricle dysfunction (defined qualitatively as "severe")
- Diagnosis of cirrhosis or end-stage liver disease
- Requires the use of mechanical circulatory support pre-operatively
- Participant uses chronic opioids (meaning at the time of the preoperative screening evaluation by the study team, the patient is prescribed and taking any opioid pain medication)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Pecto-Intercostal Fascial Plane Block for Enhanced Recovery After Cardiac Surgery
This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.
Read the detailed description
Thousands of heart surgeries are performed every day in the United States. Unattenuated perioperative pain has been shown to contribute to increased morbidity, mortality, length of stay, and healthcare costs. Practice guidelines from the American Society of Regional Anesthesiologists recommend pre-incision techniques to reduce perioperative pain, however in cardiac surgery, there are no commonly used techniques to follow this recommendation. The PIFB is a newly described fascial plane block and existing literature supports the safety and efficacy of the PIFB in cardiac surgery patients. However, there are no randomized controlled trials evaluating this technique with a long-acting depot local anesthetic.
The purpose of this study is to determine whether bilateral pecto-intercostal fascial plane blocks with liposomal bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). The primary hypothesis is that patients receiving effective regional anesthesia with liposomal bupivacaine via PIFB will demonstrate a clinically significant (25%) reduction in total daily opioid consumption through 72 hours postoperatively compared to patients receiving standard of care without effective regional anesthesia (saline only via PIFB).
This study is a prospective, single-center, randomized, double-blind, controlled trial to evaluate whether bilateral pecto-intercostal fascial plane blocks with liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline).
The participants will be randomized to receive bilateral PIFB with a mixture of standard and liposomal bupivacaine or bilateral PIFB with saline only. Recovery characteristics, including opioid consumption, pain scores, duration of mechanical ventilation, ICU length of stay, hospital length of stay, side effects, and chronic opioid use will be evaluated.
- Conditions
- Cardiac Surgery, Opioid Use, Unspecified
- Being tested
- Bupivacaine Injection, Liposomal bupivacaine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine InjectionDrug
10mL of 0.25% bupivacaine
Liposomal bupivacaineDrug
15mL of 133mg liposomal bupivacaine
SalineOther
25mL saline control
| Study group | Role | What they receive |
|---|---|---|
| PIFB intervention | Experimental | bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL) Receives: Drug: Bupivacaine Injection; Drug: Liposomal bupivacaine |
| Saline Control | Sham comparator | bilateral PIFB with 25 mL saline only Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption 72 Hours Post-operatively
Total opioid consumption during the initial 72 hours post-operatively will be measured in morphine milligram equivalents (MME) and compared between groups.
Measured: up to 72 hours post-operatively
Secondary outcomes (11)
Total Intraoperative Opioid Consumption
Total intraoperative opioid consumption will be measured in morphine milligram equivalents (MME) and compared between groups.
Measured: intraoperative period ranging from anesthesia start time to anesthesia end time
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS), beginning at time 0 (arrival to ICU). Each patient's pain scores (higher scores indicate worse pain) within each postoperative day will be averaged, and the mean pain scores during each day and throughout the first 72 hours will be compared between the intervention and control groups. Median pain scores at 24, 48 and 72 hours post-op will be interrogated.
Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).
Measured: data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively
Maximum Pain Scores up to 72 Hours Postoperatively
Pain will be assessed, according to standard of care, every 4 hours using the 9-point Numerical Rating Scale (NRS) where higher score indicate worse pain, beginning at time 0 (arrival to ICU). The number of Participants reporting a Maximum pain score at 72 hours postoperatively will be reported. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-9).
Measured: up to 72 hours post-op
Pain Score at 90 Days Postoperatively
Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS) where higher score indicate worse pain. Pain at 90 days postoperative will be surveyed by phone. Pain will be assessed participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).
Measured: up to 90 days post-op
Daily Opioid Consumption up to 72 Hours Postoperatively
Daily opioid consumption during the initial 72 hours postoperatively will be measured in milligrams of morphine equivalents and compared between groups.
Measured: up to 72 hours post-op
Hours of Mechanical Ventilation After ICU Admission
Duration of mechanical ventilation will be measured by hours of mechanical ventilation after admission to the ICU.
Measured: up to 72 hours post-op
Number of Postoperative Days Until the First Bowel Movement
Return of bowel function will be measured in the number of postoperative days until the first bowel movement.
Measured: up to 72 hours post-op
Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU)
Postoperative delirium episodes will be measured according to standard of care by utilizing the CAM-ICU assessment every 8-12 hours. The CAM-ICU determines either 'yes' or 'no' the participant is experiencing delirium. The number of of delirium episodes within 72 hours post-op will be determined.
Measured: up to 72 hours post-op
Number of Hours That the Patient is in the ICU
Duration of ICU stay will be measured by the number of hours that the patient is in the ICU until an order is placed for transfer to a lower level of care.
Measured: up to 72 hours post-op
Number of Post-operative Days Until the Patient is Discharged
Duration of hospital stay will be measured by the number of post-operative days until the patient is discharged.
Measured: Up to 7 days
Count of Participants Using Opioids at 90 Days Postoperatively
Patient use of opioids at 90 days will be obtained by phone call.
Measured: up to 90 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start28 Mar 2022
- Primary completion3 Sep 2023
- Study completion30 Nov 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, single-center, randomized, double-blind, controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Meyer, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928339
- Sponsor's protocol ID
- 2021-0111
- Other IDs
- Protocol Version 01/11/2021, A530900, SMPH/ANESTHESIOLOGY
- Status last verified
- Nov 2024
- First submitted
- 9 Jun 2021
- Last updated
- 19 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simon ER, Mallery A, Silva J, de Biasi A, Osaki S, Krause BM, Meyer P. Superficial parasternal intercostal plane blocks with liposomal bupivacaine did not significantly reduce opioid use after cardiac surgery: a randomized clinical trial. Reg Anesth Pain Med. 2025 Aug 24:rapm-2025-106952. doi: 10.1136/rapm-2025-106952. Online ahead of print.
PubMed 40850695
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pecto-Intercostal Fascial Plane Block for Enhanced Recovery After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04928339
- Acronym / sponsor ID
- 2021-0111
- Conditions
- Cardiac Surgery, Opioid Use, Unspecified
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 3 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Posted 19 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.
Detailed description
Thousands of heart surgeries are performed every day in the United States. Unattenuated perioperative pain has been shown to contribute to increased morbidity, mortality, length of stay, and healthcare costs. Practice guidelines from the American Society of Regional Anesthesiologists recommend pre-incision techniques to reduce perioperative pain, however in cardiac surgery, there are no commonly used techniques to follow this recommendation. The PIFB is a newly described fascial plane block and existing literature supports the safety and efficacy of the PIFB in cardiac surgery patients. However, there are no randomized controlled trials evaluating this technique with a long-acting depot local anesthetic.
The purpose of this study is to determine whether bilateral pecto-intercostal fascial plane blocks with liposomal bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). The primary hypothesis is that patients receiving effective regional anesthesia with liposomal bupivacaine via PIFB will demonstrate a clinically significant (25%) reduction in total daily opioid consumption through 72 hours postoperatively compared to patients receiving standard of care without effective regional anesthesia (saline only via PIFB).
This study is a prospective, single-center, randomized, double-blind, controlled trial to evaluate whether bilateral pecto-intercostal fascial plane blocks with liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline).
The participants will be randomized to receive bilateral PIFB with a mixture of standard and liposomal bupivacaine or bilateral PIFB with saline only. Recovery characteristics, including opioid consumption, pain scores, duration of mechanical ventilation, ICU length of stay, hospital length of stay, side effects, and chronic opioid use will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- prospective, single-center, randomized, double-blind, controlled trial
| Arm | Type | Receives |
|---|---|---|
| PIFB intervention | Experimental | Drug: Bupivacaine Injection, Drug: Liposomal bupivacainebilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL) |
| Saline Control | Sham comparator | Other: Salinebilateral PIFB with 25 mL saline only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant provides consent to participate in study
- Ideal body weight (IBW) is >50kg
- Participant is planned to undergo coronary artery bypass graft or single valve repair/replacement surgery via median sternotomy
- Participant is undergoing an elective procedure
Key exclusion criteria (14 listed)
- Participant is unable or unwilling to give consent
- Non-English speaking
- Known or believed to be pregnant or is currently breastfeeding
- Participant is a prisoner
- Clinically unstable per discretion of the Investigator
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 |
|---|---|---|
| Bupivacaine Injection10mL of 0.25% bupivacaine | Drug | PIFB intervention |
| Liposomal bupivacaine15mL of 133mg liposomal bupivacaine | Drug | PIFB intervention |
| Saline25mL saline control | Other | Saline Control |
Primary outcome
Total Opioid Consumption 72 Hours Post-operatively
Time frame: up to 72 hours post-operatively
Total opioid consumption during the initial 72 hours post-operatively will be measured in morphine milligram equivalents (MME) and compared between groups.
11 secondary outcomes
Total Intraoperative Opioid Consumption
Time frame: intraoperative period ranging from anesthesia start time to anesthesia end time
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op
Time frame: data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively
Maximum Pain Scores up to 72 Hours Postoperatively
Time frame: up to 72 hours post-op
Pain Score at 90 Days Postoperatively
Time frame: up to 90 days post-op
Daily Opioid Consumption up to 72 Hours Postoperatively
Time frame: up to 72 hours post-op
Hours of Mechanical Ventilation After ICU Admission
Time frame: up to 72 hours post-op
Number of Postoperative Days Until the First Bowel Movement
Time frame: up to 72 hours post-op
Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU)
Time frame: up to 72 hours post-op
Number of Hours That the Patient is in the ICU
Time frame: up to 72 hours post-op
Number of Post-operative Days Until the Patient is Discharged
Time frame: Up to 7 days
Count of Participants Using Opioids at 90 Days Postoperatively
Time frame: up to 90 days post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40850695Simon ER, Mallery A, Silva J, de Biasi A, Osaki S, Krause BM, Meyer P. Superficial parasternal intercostal plane blocks with liposomal bupivacaine did not significantly reduce opioid use after cardiac surgery: a randomized clinical trial. Reg Anesth Pain Med. 2025 Aug 24:rapm-2025-106952. doi: 10.1136/rapm-2025-106952. Online ahead of print.
- 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.
Patrick Meyer, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Injection, Liposomal bupivacaine and Saline in people with Cardiac Surgery and Opioid Use, Unspecified, run by University of Wisconsin, Madison 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 14 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 19 Nov 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 19 Nov 2024). 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?
Total Opioid Consumption 72 Hours Post-operatively (time frame: up to 72 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04928339, which also lists 1 linked publication.
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 19 Nov 2024.