Phase 2
N=79
Parasternal Nerve Block in Cardiac Patients
Coronary Artery Disease · Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT01826851 ↗Enrolled (actual)
79
Serious AEs
17.7%
Results posted
Aug 2018
Primary outcome: Primary: Median Cumulative Morphine Equivalent — 0; 2.5; 0; 5 Morphine Equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exparel (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Peter A Knight
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Cumulative Morphine Equivalent |
0; 2.5; 0; 5; 5; 8.4 | — |
| PRIMARY Median Pain Levels |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Time to Extubation (Hours) |
6.8; 6.4 | — |
| SECONDARY ICU Length of Stay (Hours) |
25; 22.8 | — |
| SECONDARY Time to First Bowel Movement (Days) |
2; 2 | — |
| SECONDARY Hospital Length of Stay (Days) |
5; 5 | — |
| SECONDARY Time to Return to Work or Daily Activities |
21.8; 21.3 | — |
Summary
Exparel is a new local analgesic (numbing medication) that is intended to be longer acting than currently available local analgesics. The purpose of this study is to determine whether use of Exparel to numb the nerves along the breastbone after open heart surgery, will decrease pain and pain medication use after surgery.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years old
- non-emergent coronary artery bypass grafting surgery (on and off pump)
- median sternotomy
Exclusion Criteria
- Concomitant cardiac procedures (e.g. aortic valve repair/replacement, mitral valve repair/replacement, aortic root replacements).
- Redo sternotomy.
- 50 kg).
- Pregnant or nursing
- History of alcohol, narcotic or illicit drug abuse
- Participation in another study evaluating investigational medications within the past 30 days
- Taking narcotic analgesics within 3 days pre-operatively or perioperative stress-dose steroids.
- Chronic non-cardiac pain (e.g. lower back pain, fibromyalgia) requiring narcotic analgesics.
- Pre-operative mild liver insufficiency as defined by liver function tests [(i.e. alanine aminotransferase (ALT), aspartate aminotransferase (AST)] ≥ 1.5 times the upper limit of normal (ULN: ALT: 0-35 U/L, AST: 0-35 U/L, Alk Phos 35-105 U/L, Total bilirubin: 0-1.2 mg/dL)
- Pre-operative mild renal insufficiency (Cr ≥ 1.5 mg/dL)
- Allergy to amide-type anesthetics
- Recurrent ventricular arrhythmias, low cardiac output requiring inotrope and/or intra-aortic balloon pump support, left ventricular ejection fraction < 30% at time of pre-operative screening/evaluation.
- Unable to provide informed consent or unable to understand how to use pain rating scales.
- Inability to understand or operate the patient-controlled analgesia (PCA) machine.
Data sourced from ClinicalTrials.gov (NCT01826851). 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.