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The postoperative patient-centred outcomes of liposomal bupivacaine combined with bupivacaine versus bupivacaine for erector spinal plane block on patients undergoing minimally invasive cardiac valve surgery : a single-center, prospective, randomized, double-blind, controlled clinical trial (PCOs of LB for ESPB in Mini Cardiac Surgery)

The postoperative patient-centred outcomes of liposomal bupivacaine combined with bupivacaine versus bupivacaine for erector spinal plane block on patients undergoing minimally invasive cardiac valve surgery : a single-center, prospective, randomized, double-blind, controlled clinical trial (PCOs of LB for ESPB in Mini Cardiac Surgery)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094353
Enrollment
Unknown
Registered
2024-12-20
Start date
2024-12-26
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Cardia valve disease

Interventions

Bupivacaine hydrochloride group (Group B):Erector spinal plane block
Liposomal bupivacaine group (Group L):Erector spinal plane block

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing minimally invasive cardiac valve surgery with elective cardiopulmonary bypass via intercostal incision 2. No gender limitation, age between 18 and 80 years old 3. ASA classification I-III 4. EuroScore <5 5. Body mass index (BMI) <31 kg/m^2 6. Understand and administer the Postoperative Intravenous Analgesia Pump (PCIA) independently or with assistance

Exclusion criteria

Exclusion criteria: 1. Refuse to participate or unable to communicate 2. Participating in other clinical trials 3. Contraindications of nerve block, including infection at puncture site, severe coagulopathy and severe spinal deformity 4. Patients with neurocognitive impairment (NCD), depression and other mental diseases before surgery, or unable to complete the postoperative scale 5. Patients or accompanying family members were serious anxious before surgery 6. Long-term use of analgesics, or known abuse of alcohol, drugs or narcotic drugs 7. Accompanied by other conditions, such as breastfeeding, pregnancy, tumor, severe disability, etc.

Design outcomes

Primary

MeasureTime frame
QoR-15 score;

Secondary

MeasureTime frame
Patient satisfaction;VAS scores at rest and cough;The first PCIA blous time;PCIA blous times;breakthrough pain;Postoperative remedial analgesia;Postoperative nausea and vomiting, skin itching, delirium;Mechanical ventilation time;Postoperative death and major complications;Chronic pain;

Countries

China

Contacts

Public ContactKefang Guo

Zhongshan Hospital, Fudan University

guo.kefang@zs-hospital.sh.cn+86 21 6404 1990

Outcome results

None listed

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