Phase 3
N=60
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
Coronary Artery Disease · Coronary Artery Stenoses · Valve Regurgitation, Mitral · Valve Regurgitation, Tricuspid
Bottom Line
View on ClinicalTrials.gov: NCT03270514 ↗Enrolled (actual)
60
Serious AEs
16.7%
Results posted
Sep 2021
Primary outcome: Primary: Post-operative Pain Intensity — 4.7482; 5.03; 5.75; 6.64 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Exparel Injectable Product (Drug); Bupivacaine Hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kathirvel Subramaniam
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Pain Intensity |
4.7482; 5.03; 5.75; 6.64; 4.7262; 4.996 | — |
| PRIMARY Total Narcotic Consumption |
15; 10; 45; 34.5; 45; 45 | — |
| SECONDARY Time to Extubation |
3.85; 3.47 | — |
| SECONDARY Patient Time to Mobilization |
42; 45 | — |
| SECONDARY Patient Time to Out of Bed to Chair |
16; 16 | — |
| SECONDARY Patient Time to Oral Intake |
7; 5.6 | — |
| SECONDARY Non-invasive Ventilation (NIV) Requirement |
6; 5 | — |
| SECONDARY Re-intubation |
3; 3 | — |
| SECONDARY Use of Incentive Spirometry |
29; 31 | — |
| SECONDARY Post-operative Nausea and Vomiting |
3; 9 | — |
| SECONDARY Major Organ Dysfunction |
1; 0; 1; 1; 0; 1 | — |
| SECONDARY Length of Hospital and ICU Stay |
1.51; 1.71; 7; 6 | — |
| SECONDARY Hospital Readmission |
3; 3 | — |
| SECONDARY Mortality |
0; 1 | — |
Summary
The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration
Eligibility Criteria
Inclusion Criteria
- Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass)
- Surgery with the use of cardiopulmonary bypass
Exclusion Criteria
- Minimally invasive heart surgery through thoracotomy approach
- Patient undergoing procedures under deep hypothermic circulatory arrest
- Patients with active infections such as infective endocarditis
- Emergency surgery
- Patients undergoing transplantations and ventricular assist device insertion
- Patients on any mechanical circulatory support preoperatively
- Patient's refusal
- End stage liver or renal disease
- Allergy to bupivacaine
- Patient who cannot understand the study procedure or refuse to participate
- Redo-sternotomy
- Participation in another study
- Patients with severe right or left ventricular dysfunction (EF< 25%)
- Patients requiring chronic opioids for chronic pain condition
Data sourced from ClinicalTrials.gov (NCT03270514). 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.