Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Fracture Surgery

Sponsor
Peking University First Hospital
Study ID
NCT07643792
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Fascia Iliaca Block
  • Hip Fracture Surgery
  • Liposomal Bupivacaine
  • Older Adults
  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Liposomal bupivacaine (LB) — DRUG
    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 — DRUG
    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 Details

Older patients with hip fractures 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.

Key Dates

First listed
Jun 12, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal bupivacaine group
    Participants in this arm will receive a single preoperative ultrasound-guided supra-inguinal fascia iliaca block. The mixture used for nerve block will consist of 10 mL of 0.5% plain bupivacaine plus 20 mL of liposomal bupivacaine (266 mg), for a total volume of 30 mL. The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip position between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area.
  • Active Comparator: Plain bupivacaine group
    Participants in this arm will receive a single preoperative ultrasound-guided supra-inguinal fascia iliaca block. The mixture used for nerve block will consist of 30 mL of 0.5% plain bupivacaine (total 150 mg). The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip position between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area.

Primary Outcome Measure

The area under curve of pain intensity within 72 hours after surgery [ Time Frame: Up to 72 hours after the surgery ]

Central Contacts

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