Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07643792

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location contact

Dong-Xin Wang, MD, PhD

CONTACT

[email protected]

010-83572784

About this study

Hip fracture is a global health concern. Data from 204 countries over the past 30 years show an increasing incidence of hip fractures in people over 55 years old. With population aging, China is projected to have 1.3 million new geriatric hip fracture cases annually by 2050, imposing a heavy burden on individuals, families, and healthcare systems. Timely surgery remains the preferred treatment.

Optimizing analgesia through multimodal strategies can enhance postoperative recovery and shorten hospital stays. Peripheral nerve blocks (PNB), particularly ultrasound-guided femoral nerve block or supra-inguinal fascia iliaca compartment block (FICB), have been shown to reduce pain and opioid consumption after hip surgery. A recent prospective cohort study indicated that better perioperative pain control with PNB is associated with lower opioid needs and shorter hospitalization.

Conventional local anesthetics like ropivacaine or bupivacaine provide analgesia for about 12 hours, which is insufficient for the entire perioperative period. Liposomal bupivacaine, an extended-release formulation, can provide analgesia for up to 72 hours. Some studies have demonstrated benefits of liposomal bupivacaine for nerve blocks in thoracic and hip surgeries, including improved recovery quality, reduced opioid use, and lower pain scores at 24-72 hours. However, evidence remains controversial; several meta-analyses suggest that while statistical differences exist, clinical relevance may be limited.

Inadequate pain control negatively affects postoperative outcomes and is associated with delirium, myocardial injury, and pulmonary complications-especially in vulnerable older patients with reduced physiological reserve and multiple comorbidities. Therefore, this randomized controlled trial aims to investigate whether preoperative FICB using liposomal bupivacaine combined with plain bupivacaine can provide superior perioperative analgesia compared with plain bupivacaine alone in older (≥55 years) patients undergoing hip fracture surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 55 years.
  • Diagnosed as hip fracture and 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.

Treatment and study plan

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.

Primary outcomes

  1. The area under curve of pain intensity within 72 hours after surgery

    Time frame: 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.

Secondary outcomes

  1. Cumulative opioid consumption within 72 hours after surgery

    Time frame: Up to 72 hours after the surgery

    Cumulative opioid consumption will be calculated as intravenous morphine equivalent dosage.

  2. Incidence of cardiovascular events within 7 days after surgery

    Time frame: Up to 7 days after surgery

    Cardiovascular events includes myocardial injury, non-fatal cardiac arrest, and all-cause death.

Other outcomes

  1. Incidence of moderate-to-severe pain within 72 hours after surgery

    Time frame: Up to 72 hours after surgery

    Moderate-to-severe pain is defined as a NRS pain score of 4 or higher at any timpoint.

  2. The proportion of patients receiving rescue analgesics within 72 hours after surgery.

    Time frame: Up to 72 hours after surgery

    Rescue analgesics are defined as any analgesic drugs other than PCIA, including opioids, acetaminophen, non-steroid anti-inflammatory drugs, and other analgesics.

  3. Cumulative score of subjective sleep quality during the first three nights after surgery

    Time frame: Up to three nights after surgery

    Subjective sleep quality will be assessed with the numeric rating scale (NRS; an 11-point where 0=the best sleep and 10=the worst sleep).

  4. Quality of recovery at 24 hours after surgery

    Time frame: At 24 hours after surgery

    Quality of recovery will be assessed with the quality of recovery-15 (QoR-15; a 15-item questionnaire that evaluat the quality of early postoperative recovery after surgery and anesthesia. Scores range from 0 to 150, with higher scores indicating better quality of recovery).

  5. Incidence of acute kidney injuy within 7 days after surgery

    Time frame: Up to 7 days after surgery

    Acute kidney injury (AKI) will be diagnosed according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) creatinine criteria. AKI is diagnosed if any one of the following criteria is met: (1) An increase in serum creatinine (SCr) by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours; (2) An increase in serum creatinine to ≥ 1.5 times the baseline value, which is confirmed or presumed to have occurred within the past 7 days.

  6. Length of hospital stay after surgery

    Time frame: Up to 30 days after surgery

    Length of hospital stay after surgery

  7. Incidence of complications within 30 days after surgery

    Time frame: Up to 30 days after surgery

    Postoperative complications are generally defined as new-onset conditions that are deemed harmful and required therapeutic intervention, i.e., grade 2 or higher on the Clavien-Dindo classification.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong-Xin Wang, MD, PhD

CONTACT

[email protected]

010-83572784

Zhen Zhang, MD

CONTACT

[email protected]

+86 13681035526

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Fracture Surgery: a Randomized Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.