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Efficacy and safety of local infiltration of bupivacaine liposome injection for acute pain management in elderly patients undergoing hip fracture surgery: a pragmatic,randomized controlled multicenter trial

Efficacy and safety of local infiltration of bupivacaine liposome injection for acute pain management in elderly patients undergoing hip fracture surgery: a pragmatic,randomized controlled multicenter trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094484
Enrollment
Unknown
Registered
2024-12-24
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Hip fracture

Interventions

Experimental Group:In the experimental group, bupivacaine liposome injection was used for local infiltration analgesia before the surgical wound was closed, and the specific method was to infiltrate t
Control group:None

Sponsors

Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age> = 65 years old, gender is not limited. 2. Diagnosed with hip fracture (including femoral neck, intertrochanteric or subtrochanteric fracture) and planned to undergo surgery within 48 hours of diagnosis. 3. The American Society of Anesthesiologists (ASA) grading standard is I.~III. 4. Subjects have a detailed understanding of the nature, significance and potential risks of the trial, and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Cognitive and communication disorders. 2. Unable to walk normally before the fracture. 3. Patients with multiple injuries or severe heart block and unstable coronary heart disease. 4. Presence of severe liver or renal system disease. 5. Patients with coagulation dysfunction or who have not stopped anticoagulants before surgery. 6. Patients with a history of opioid or amide local anesthetic allergy. 7. Subjects who have participated in other clinical trials within 3 months prior to randomization.

Design outcomes

Primary

MeasureTime frame
Proportion of patients who were ambulatory from the end of surgery to 24 hours after surgery;

Secondary

MeasureTime frame
Proportion of patients who were able to get out of bed within 48 hours and 72 hours after surgery;Opioid consumption at 24 hours, 48 hours, and 72 hours after surgery;Pain intensity scores (NRS) at 24 hours, 48 hours and 72 hours after surgery;

Countries

China

Contacts

Public ContactWeitao Jia

Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University

jiaweitao@shsmu.edu.cn+86 189 3017 3389

Outcome results

None listed

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