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The efficacy and safety of bupivacaine liposome injection for postoperative pain treatment after minimally invasive cardiac surgery: A single-center, prospective, randomized, single-blind, controlled trial

The efficacy and safety of bupivacaine liposome injection for postoperative pain treatment after minimally invasive cardiac surgery: A single-center, prospective, randomized, single-blind, controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107741
Enrollment
Unknown
Registered
2025-08-18
Start date
2025-08-31
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease

Interventions

Bupivacaine liposome group:At the end of the patients surgery, bupivacaine liposome injection was used for nerve block (including thoracic rectus muscle nerve block, erector spinae plane block or ante
Normal saline group:At the end of surgery, patients were treated with normal saline injection for nerve blocks (including transverse pectoralis nerve block, erector spinae plane block, or serratus ant

Sponsors

Fuwai Huaxin Cardiovascular Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Before the trial, thoroughly understand the nature, significance and potential benefits of the trial, be able to comprehend the procedures and methods of this research, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form; 2.Schedule a minimally invasive cardiac surgery; 3. Age >= 18 years old;

Exclusion criteria

Exclusion criteria: 1. Patients with combined psychiatric disorders and cognitive dysfunction; 2. Patients with sensory disorders such as hyperalgesia, or other somatic pain that affects postoperative pain assessment; 3. Patients with a history of myocardial infarction or unstable angina within the past six months, or a history of severe arrhythmia (such as second-degree and above atrioventricular block); 4. Patients with diabetic peripheral neuropathy; 5. Patients known to be allergic to bupivacaine or other amide-type local anesthetics; 6. Pregnant or lactating patients, as well as female patients who have a fertility plan within the past six months and are unwilling or unable to take effective contraceptive measures; 7. Patients considered by the researchers to have any other factors that make them unsuitable for participating in this trial.

Design outcomes

Primary

MeasureTime frame
The NRS score in the resting state at 24 hours (+/-1 hour) after the surgery.;

Countries

China

Contacts

Public ContactLin Hongqi

Fuwai Huaxin Cardiovascular Hospital

16637066966@163.com+86 166 3706 6966

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026