Phase 3
Completed N=80
Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
Coronary Artery Disease · Sternal Pain
Source: ClinicalTrials.gov NCT03482973 ↗
Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Aug 2020
Primary outcomePrimary: Opioid Consumption — 40.8; 49.1 Milligram Morphine Equivalents (MME)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Consumption |
40.8; 49.1 | — |
| SECONDARY Pain Scores |
4.8; 5.1 | — |
| SECONDARY ICU Length of Stay |
1.2; 1.7 | — |
| SECONDARY Hospital Length of Stay |
8; 7.5 | — |
| SECONDARY Number of Participants With Complications |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients 18 years of age or older
- Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and isolated valve surgeries.
Exclusion Criteria
- Current participation in another interventional study
- Preoperative LVEF < 30%
- Use of mechanical circulatory support
- Emergent procedures
- Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts
- Minimally invasive cardiac procedures or those with thoracotomy approach
- Patients receiving other modalities of regional anesthesia like intrathecal morphine
- Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
- Current use of TCA, gabapentin, or pregabalin
- Hypersensitivity to bupivacaine
- Women who are pregnant or breastfeeding
- Non English speaking
Data sourced from ClinicalTrials.gov (NCT03482973). 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.