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Liposomal Bupivacaine in Combined Adductor Canal-Popliteal Sciatic Nerve Block for Acute Postoperative Pain Management in elderly Patients after Total Knee Arthroplasty: A Prospective,Randomized, Double-Blind Trial

Liposomal Bupivacaine in Combined Adductor Canal-Popliteal Sciatic Nerve Block for Acute Postoperative Pain Management in elderly Patients after Total Knee Arthroplasty: A Prospective,Randomized, Double-Blind Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098128
Enrollment
Unknown
Registered
2025-03-03
Start date
2025-03-03
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Acute postoperative pain

Interventions

Liposomal bupivacaine group:The patients will receive combined adductor canal-popliteal sciatic nerve block of 20 ml 133 mg liposome bupivacaine on the affected side 30 min before surgery.
Ropivacaine group:The patients will receive combined adductor canal-popliteal sciatic nerve block of 20 ml 40mg ropivacaine (0.2%) on the affected side 30 min before surgery.

Sponsors

Zhongda Hospital Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: Age>=65 years; American Society of Anesthesiologists Class I.-III; Patients who are scheduled for unilateral total knee arthroplasty TKA.

Exclusion criteria

Exclusion criteria: Subject refuses to sign the consent form; preoperative delirium or consideration of drugs to treat delirium; Preoperative presence of psychiatric diseases such as Parkinson's, Alheimers, and depression; History of long-term daily opioid use (more than 1 month) and oral morphine equivalent greater than 5 mg/day; Body mass index (BMI) greater than 40kg/m^2; allergy to bupivacaine, contraindications to regional anesthesia; New York Heart Association (NYHA) class III-IV or acute myocardial infarction; Patients with severe liver and kidney disease: abnormal liver function with a Child-Pugh grading score of =8, renal impairment requiring dialysis (serum creatinine >707umol/L or glomerular filtration rate =442umol/L or a daily increase of >177umol/L); Predicted postoperative transfer to ICU; Poor compliance of subjects, use of other drugs or methods that affect the outcome indicators of the trial; Follow-up failure of the subject.

Design outcomes

Primary

MeasureTime frame
Area under the time-weighted curve of NRS pain score at rest within 72 hours after surgery;Area under the time-weighted curve of NRS pain score at motion within 72 hours after surgery;

Secondary

MeasureTime frame
Area under the time-weighted curve of NRS pain score at rest within each 24h after surgery;Area under the time-weighted curve of NRS pain score at motion within each 24h after surgery;Cumulative opioid consumption during 0-24h, 24-48h, 48-72h after surgery and total cumulative opioid consumption during 72h after surgery (converted to morphine equivalents);Time (min) from the end of surgery to the first need for rescue analgesia within 72 hours after surgery;Occurrence of perioperative neurocognitive disorders within 72 hours after surgery;Occurrence of sleep disorders;

Countries

China

Contacts

Public ContactTian Mi

Zhongda Hospital Southeast University

candytianmi@126.com+86 139 1304 9496

Outcome results

None listed

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