To evaluate the safety and efficacy of liposomal bupivacaine for deep parasternal intercostal plane block

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500111089

Enrollment

Unknown

Registered

2025-10-24

Start date

2024-05-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Postoperative pain in patients undergoing median thoracotomy during cardiac surgery

Interventions

LBB group:Patients were subjected to deep intercostal plane block before induction of anesthesia with 40ml, 0.665% bupivacaine liposome (20ml, 266 mg bupivacain

RPB group:Patients before anesthesia induction, using 40 ml, 0.375% ROM pp because solution for deep sternal side rib between plane block

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Fully understand the purpose, process, potential benefits and risks of the study, and voluntarily sign informed consent; 2. Plan to undergo elective open heart surgery by the same medical team; 3. Age of 18-65 years old, both sexes; 4. Body weight meets the criteria: men >=50kg, women >=45kg, BMI between 19.0 and 26.0kg/m²; 5. ASA grade ?-?.

Exclusion criteria

Exclusion criteria: 1. Refusing to accept deep parasternal intercostal plane block; 2. previous history of allergic diseases (such as asthma, urticaria, eczema, etc.) or allergy to bupivacaine; 3. Skin damage or infection in the chest wall area; 4. abnormal coagulation function (APTT > 33.8S or PT > 12.1S, the reference value was based on the standards of the laboratory department of our hospital); 5. history of chronic neuropathic pain; 6. participating in other clinical research at the same time.

Design outcomes

Primary

Measure	Time frame
Changes in pain scores within 72 days after surgery;quality of recovery;	—

Secondary

Measure	Time frame
Mean arterial pressure;heart rate;Perioperative satisfaction;Time to first use of analgesics;Extubation time;Serum concentrations of TNF-a, IL-1ß and IL-6 were measured;ICU dwell time;Time to first exhaust bowel movements;Incidence of postoperative pruritus;the first time of out of bed;The amount of opioid analgesics used after surgery;Length of hospital stay;hospitalization expenses;Quality of sleep after surgery;Adverse event rate;	—

Measure

Time frame

Mean arterial pressure;heart rate;Perioperative satisfaction;Time to first use of analgesics;Extubation time;Serum concentrations of TNF-a, IL-1ß and IL-6 were measured;ICU dwell time;Time to first exhaust bowel movements;Incidence of postoperative pruritus;the first time of out of bed;The amount of opioid analgesics used after surgery;Length of hospital stay;hospitalization expenses;Quality of sleep after surgery;Adverse event rate;

—

Countries

China

Contacts

Public ContactShibiao Chen

The First Affiliated Hospital of Nanchang University

chenlaoshi1111@163.com+86 138 7098 2918

Outcome results

None listed

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