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Exploratory study of Liposomal Bupivacaine for Adductor Canal Blocks in Total Knee Arthroplasty

Exploratory study of Liposomal Bupivacaine for Adductor Canal Blocks in Total Knee Arthroplasty

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084532
Enrollment
Unknown
Registered
2024-05-20
Start date
2024-05-25
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

None

Interventions

Group T:199mg bupivacaine liposome + 5 ml of NS in total 20ml for ACB
Group C:0.5% bupivacaine 20ml for ACB

Sponsors

The First Affiliated Hospital of Xinxiang Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 years old, with no gender limit; 2. ASA grades I-III; 3. Patients undergoing unilateral total knee replacement (TKA) under general anesthesia; 4.18 kg/m2<BMI<30kg/m2 5. Agreed to follow the study protocol and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. dication to local anesthetic or other study drugs, general anesthesia and / or adductor tube block 2. Medical history or evidence of increasing the risk of anesthesia during the screening period: ? Cardiovascular system: New York Heart Association (NYHA) grade III, IV heart failure, and (Adams-stokes) syndrome (ACS); requiring medication for bradycardia and / or heart rate 50 beats / min; history of severe arrhythmias including II-III degree atrioventricular block (excluding patients using pacemakers); acute and chronic myocarditis; patients requiring vasoactive drugs to maintain normal blood pressure; ? Patients with psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive dysfunction; previous history of psychotropic drugs and narcotic drug abuse; previous history of alcohol abuse within 3 months before the screening period; ? Severe hepatic and renal insufficiency (liver function: refer to child-pugh C; renal function: glomerular filtration rate eGFR 30 mL / (min * 1.73 ?) [eGFR calculated using nephrology modified dietary test (MDRD) formula: eGFR=175 serum creatinine (Scr) -1.234 age-0.1790.79 (female)]; dialysis patients; ? Severe respiratory diseases, major seizure status, convulsions; craniocerebral injury, intracranial hypertension, cerebral aneurysm; 3. Pregnant and lactating women 4. Participate in the clinical trials of other drugs within 1 month before the screening 5. Other circumstances where the investigator determines that the patient is not fit to participate in the clinical trial

Design outcomes

Primary

MeasureTime frame
VAS score (Resting and movement);

Secondary

MeasureTime frame
The condition of limb movement;Opioid dosage;Adverse drug reactions and sleep conditions;

Countries

China

Contacts

Public ContactYongqiang Zhang

The First Affiliated Hospital of Xinxiang Medical College

247932723@qq.com+86 185 6756 9956

Outcome results

None listed

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