Phase 4
Completed N=100
Pecto-Intercostal Fascial Plane Block Study
Cardiac surgery · Opioid Use, Unspecified
Source: ClinicalTrials.gov NCT04928339 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Total Opioid Consumption 72 Hours Post-operatively — 165.00; 205.05 morphine milligram equivalents
◆ Published Evidence
Emerging
4citations · ~4 / year
Superficial parasternal intercostal plane blocks with liposomal bupivacaine did not significantly reduce opioid use after cardiac surgery: a randomized clinical 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). 100 participants will be recruited and can expect to be on study for 100 days.
Linked Publications
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Superficial parasternal intercostal plane blocks with liposomal bupivacaine did not significantly reduce opioid use after cardiac surgery: a randomized clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Consumption 72 Hours Post-operatively |
165.00; 205.05 | — |
| SECONDARY Total Intraoperative Opioid Consumption |
267.50; 229.80 | — |
| SECONDARY Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op |
46; 47; 2; 1; 2; 2 | — |
| SECONDARY Maximum Pain Scores up to 72 Hours Postoperatively |
29; 25; 19; 22; 2; 3 | — |
| SECONDARY Pain Score at 90 Days Postoperatively |
3; 2; 0; 0; 2; 1 | — |
| SECONDARY Daily Opioid Consumption up to 72 Hours Postoperatively |
90; 103.80; 58.35; 75.00; 26.25; 30.00 | — |
| SECONDARY Hours of Mechanical Ventilation After ICU Admission |
4.03; 4.46 | — |
| SECONDARY Number of Postoperative Days Until the First Bowel Movement |
2.81; 2.60 | — |
| SECONDARY Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU) |
5; 8 | — |
| SECONDARY Number of Hours That the Patient is in the ICU |
20.94; 20.00 | — |
| SECONDARY Number of Post-operative Days Until the Patient is Discharged |
4.60; 4.51 | — |
| SECONDARY Count of Participants Using Opioids at 90 Days Postoperatively |
2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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)
Data sourced from ClinicalTrials.gov (NCT04928339) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.