Using liposomal bupivacaine for pain management in cardiac surgery
Regional Blockade of the Sternum With Liposomal Bupivacaine Prior to Incision Decreases Opioid Use in Patients Undergoing Cardiac Surgery (Sternal Block)
PHASE4 · Baylor Research Institute · NCT04333095
This study is testing if a new pain medication called liposomal bupivacaine can help patients feel less pain and use fewer opioids after heart surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor Research Institute (other) |
| Locations | 1 site (Plano, Texas) |
| Trial ID | NCT04333095 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of liposomal bupivacaine on pain management for patients undergoing sternotomy in cardiac surgery. The medication will be administered before the surgical incision to assess its impact on postoperative pain levels and opioid usage compared to saline. The study aims to enhance recovery by potentially reducing the need for narcotics and improving overall pain management. Participants will be monitored for approximately 72 hours post-surgery or until discharge.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are scheduled for surgical procedures involving mini- or full sternotomy.
Not a fit: Patients with clinical instability, severe obesity, or chronic opioid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and opioid consumption for cardiac surgery patients.
How similar studies have performed: Previous studies have shown positive outcomes with local analgesia in cardiac surgery, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age greater than 18 years 2. Undergoing a surgical procedure through mini- or full sternotomy. Exclusion Criteria: 1. Clinical instability 2. Allergic to liposomal bupivacaine solution or any of its ingredients 3. Maximum-allowed dosage of local analgesia will be exceeded by the injection amount of liposomal bupivacaine used in this study (\<50 kg). 4. BMI \>45 5. Pregnant or nursing 6. Chronic home opioid usage 7. Left Ventricular Ejection Fraction (LVEF) \< 30% 8. Low cardiac output requiring mechanical or inotropic support 9. End-stage renal disease 10. Cirrhosis
Where this trial is running
Plano, Texas
- Baylor Scott & White Heart Hospital - Plano — Plano, Texas, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiovascular Surgery, Pain, Postoperative, Block