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A Prospective, Multicenter, Randomized Controlled Study Evaluating the Efficacy and Safety of Liposomal Bupivacaine for Postoperative Analgesia in Patients Undergoing Total Aortic Arch Replacement Surgery

A Prospective, Multicenter, Randomized Controlled Study Evaluating the Efficacy and Safety of Liposomal Bupivacaine for Postoperative Analgesia in Patients Undergoing Total Aortic Arch Replacement Surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107805
Enrollment
Unknown
Registered
2025-08-19
Start date
2025-08-25
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Postoperative Analgesia

Interventions

Intervention group: Liposomal bupivacaine 266 mg (20 mL diluted to a total injectable volume of 50 mL) was administered as a combined bilateral superficial parasternal intercostal fascial infiltration
Control group:Control group: Normal saline 50 mL was administered using the identical infiltration technique (bilateral parasternal intercostal fascial and rectus sheath sites) at the same procedural

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of type A aortic dissection (TAAD) confirmed by contrast-enhanced computed tomography (CT), in accordance with the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease; 2. Age 18–70 years, BMI 18.5–35 kg/m²; GERAADA score <=4; 3. Scheduled for total aortic arch replacement under cardiopulmonary bypass (CPB); 4. Ability to comprehend and assess Visual Analog Scale (VAS) scores and operate an intravenous patient-controlled analgesia (PCA) pump; 5. Provision of written informed consent and willingness to complete follow-up.

Exclusion criteria

Exclusion criteria: 1. Intraoperative conversion to hemiarch replacement or debranching procedures; 2. Redo sternotomy; 3. Pregnancy, lactation, or planned conception during the study period; 4. Active systemic or cardiopulmonary infection; 5. Severe coagulopathy or bleeding tendency; 6. Preoperative requirement for mechanical ventilation; 7. Use of mechanical circulatory support devices; 8. Contraindications or hypersensitivity to local anesthetics; 9. Chronic pain history (>3 months); 10. Preoperative opioid use =15 mg morphine equivalents/day for =15 days within 30 days prior to surgery; 11. Clinically significant neurological deficits (e.g., spinal cord injury, paralysis, or neurological impairment in the block area); 12. Severe renal/hepatic dysfunction (serum creatinine >2 mg/dL [176.8 µmol/L], blood urea nitrogen >50 mg/dL [17.9 mmol/L], aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >3× upper limit of normal); 13. Neurological/psychiatric disorders interfering with postoperative assessments; 14. Concurrent participation in other clinical trials; 15. Other investigator-determined contraindications.

Design outcomes

Primary

MeasureTime frame
QoR-15 score;

Secondary

MeasureTime frame
(Overall Benefit of Analgesic Scale,OBAS);Cumulative Analgesic Consumption in Morphine Equivalents;Time to First Rescue Analgesic Requirement Postoperatively;

Countries

China

Contacts

Public ContactSheng Wang, Peirong Lin

Beijing Anzhen Hospital, Capital Medical University

lalunalin@163.com+86 186 1116 5337

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026