Comparing liposomal bupivacaine and regular bupivacaine for pain relief after heart surgery
Liposomal Bupivacaine and Bupivacaine Alone Transverse Thoracic Muscle Plane Blocks in Median Sternotomy: a Prospective, Single-blind, Randomized Controlled Study
This study is testing whether a new type of pain relief medicine, liposomal bupivacaine, works better than regular bupivacaine for people recovering from heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06646172 on ClinicalTrials.gov |
What this trial studies
This study investigates the postoperative pain relief effects of liposomal bupivacaine combined with bupivacaine hydrochloride versus bupivacaine hydrochloride alone in patients undergoing median sternotomy. The research aims to provide evidence-based guidance for selecting the most effective local anesthesia for regional blocks in cardiac surgery. By utilizing the Transverse Thoracic Muscle Plane Block (TTMPB) technique, the study seeks to minimize opioid use and its associated side effects, improving patient recovery and quality of life. The trial will include patients aged 18-90 who are classified as ASA Class I to III and are undergoing elective surgeries.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-90 years undergoing elective median sternotomy with ASA Class I to III.
Not a fit: Patients who may not benefit include those undergoing emergency surgeries, re-operations, or those with significant comorbidities affecting anesthesia safety.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing cardiac surgery, reducing reliance on opioids.
How similar studies have performed: Other studies have shown promise in using regional anesthesia techniques, but this specific comparison of liposomal versus regular bupivacaine is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-90 years; * ASA Class I \~ III; * Patients undergoing elective median sternotomy. Exclusion Criteria: * Emergency surgery; * Re-operation; * Coagulation dysfunction; * Preoperative left ventricular function was poor (ejection fraction \<35%); * Systemic infection or injection site infection; * Neuromuscular diseases; * Mental illness; * Dependence on psychotropic drugs; * Allergic to bupivacaine liposomes and bupivacaine; * Patients have participated in previous trials or have been determined by a surgeon or anesthesiologist to be unsuitable for randomization; * Failure to obtain written informed consent from the patient or his/her representative
Where this trial is running
Wuhan, Hubei
- Tianzhu Liu — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Liu Tianzhu, M.D.
- Email: liutzh@126.com
- Phone: 13098866448
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.