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Starting soon Phase 4

Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Surgery

NCT07643792 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2026-08
Last updated
2026-08-11

Condition(s) studied

Fascia Iliaca BlockLiposomal BupivacainePostoperative PainHip Surgery

Investigational drug(s) / intervention(s)

Liposomal bupivacaine (LB) →Plain bupivacaine →

Liposomal bupivacaine (LB): A single preoperative ultrasound-guided supra-inguinal fascia iliaca block will be perfomed using a mixture of 10 mL of 0.5% plain bupivacaine plus 20 mL of liposomal bupivacaine (266 mg), total volume 30 mL. The injection will be performed after negative aspiration and under real-time ultrasound visualization to ensure proper spread between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area.

Plain bupivacaine: A single preoperative ultrasound-guided supra-inguinal fascia iliaca block will be performed using 30 mL of 0.5% plain bupivacaine (150 mg). The injection will be performed after negative aspiration and under real-time ultrasound visualization to ensure proper spread between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area.

Study summary

Patients after hip surgery often suffer from severe pain. Inadequate analgesia increases the risk of postoperative delirium, myocardial injury, and other complications. Peripheral nerve block is an important component of multimodal analgesia, but conventional local anesthetics (such as plain bupivacaine) provide only approximately 12 hours of analgesic duration, which is far from covering the most painful 72 hours after surgery. Liposomal bupivacaine has a slow-release property, prolonging the analgesic duration up to 72 hours after a single injection. However, its clinical advantages in hip fracture surgery remain controversial. The investigators suppose that, compared with plain bupivacaine alone, preoperative supra-inguinal fascia iliaca block using liposomal bupivacaine combined with plain bupivacaine can further improve analgesia, decrease opioid consumption, and improve postoperative recovery quality within 72 hours in older patients after hip fracture surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Aged ≥ 18 years. * Scheduled to undergo hip replacement surgery. * Agree to receive regional nerve block and postoperative patient-controlled intravenous analgesia (PCIA). Exclusion Criteria: * Inability to communicate due to visual, auditory, language, or other reasons before surgery. * Chronic opioid dependence and long-term use of various types of analgesics (for more than 3 months). * Severe coagulation abnormalities (International Normalized Ratio \> 1.7, activated partial thromboplastin time exceeding the normal value by more than 4 seconds, platelet count \< 80 × 10⁹/L), trauma or infection at the intended puncture site, or severe low back pain. * Preoperative severe renal insufficiency (serum creatinine \> 442 μmol/L or requiring renal replacement therapy), hepatic insufficiency (Child-Pugh class C), or ASA physical status \> IV. * Known allergy to local anesthetics. * Any other condition that the investigator or attending physician deems unsuitable for participation in the study.

Primary outcome measure(s)

  • The area under curve of pain intensity within 72 hours after surgery — Up to 72 hours after the surgery
    Pain intentsity will be assessed with the numeric rating scale (NRS; an 11-point where 0=no pain and 10=the worst pain) at 2, 6, 12 hours and then very 12 hours, until 72 hours after surgey. The area under curve of pain intensity will be calculated using the trapezoidal rule.

Trial sites (1)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07643792 on ClinicalTrials.gov ↗ ← All trials in China