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Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Surgery

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07643792
Enrollment
148
Registered
2026-06-12
Start date
2026-08-01
Completion date
2028-08-01
Last updated
2026-08-11

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

Conditions

Fascia Iliaca Block, Liposomal Bupivacaine, Postoperative Pain, Hip Surgery

Keywords

Fascia Iliaca Block, Liposomal Bupivacaine, Postoperative Pain, Hip surgery

Brief 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.

Detailed description

Hip joint diseases are among the major disorders that impair patients' motor function and quality of life. With the acceleration of population aging and the advancement of hip reconstruction techniques, the number of patients undergoing hip arthroplasty has continued to increase. Hip arthroplasty primarily includes hemiarthroplasty and total hip arthroplasty (THA), with indications covering a variety of diseases and injuries, including osteonecrosis of the femoral head, hip osteoarthritis, ankylosing spondylitis, developmental dysplasia of the hip, and other conditions that lead to structural destruction and functional impairment of the hip joint. Hip arthroplasty can effectively relieve pain, improve joint function, and enhance patients' quality of life, and has become an important treatment modality for end-stage hip joint diseases. 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.

Interventions

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.

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.

Sponsors

Peking University First Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
The area under curve of pain intensity within 72 hours after surgeryUp to 72 hours after the surgeryPain 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

MeasureTime frameDescription
Cumulative opioid consumption within 72 hours after surgeryUp to 72 hours after the surgeryCumulative opioid consumption will be calculated as intravenous morphine equivalent dosage.
Incidence of cardiovascular events within 7 days after surgeryUp to 7 days after surgeryCardiovascular events includes myocardial injury, non-fatal cardiac arrest, and all-cause death.

Countries

China

Contacts

CONTACTDong-Xin Wang, MD, PhD
wangdongxin@hotmail.com010-83572784
CONTACTZhen Zhang, MD
zhangzhen1st@163.com+86 13681035526
PRINCIPAL_INVESTIGATORDong-Xin Wang, MD, PhD

Peking University First Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026