Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
NCT Number: NCT07643792
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100034, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Up to 72 hours after the surgery
Cumulative opioid consumption will be calculated as intravenous morphine equivalent dosage.
Time frame: Up to 7 days after surgery
Cardiovascular events includes myocardial injury, non-fatal cardiac arrest, and all-cause death.
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.
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.
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).
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).
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.
Time frame: Up to 30 days after surgery
Length of hospital stay 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.
Contact information is provided by the study sponsor or research team.
Dong-Xin Wang, MD, PhD
CONTACT
Zhen Zhang, MD
CONTACT
Peking University First Hospital
Other
Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Surgery: a Randomized Trial
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.
NCT02108847
Arthroplasty, Replacement, Hip, Fascia Iliaca Block
Saskatoon, Saskatchewan, Canada
View Trial DetailsNCT06773780
Aortic Valve Disease, Aortic Valve Stenosis
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06573931
Agnosia, Analgesia
Tanta, El-Gharbia, Egypt
View Trial DetailsNCT06614010
Confusion, Delirium
Jinan, Shandong, China
View Trial Details