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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal bupivacaine group | Experimental | 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. |
|
| Plain bupivacaine group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The area under curve of pain intensity within 72 hours after 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. | Up to 72 hours after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative opioid consumption within 72 hours after surgery | Cumulative opioid consumption will be calculated as intravenous morphine equivalent dosage. | Up to 72 hours after the surgery |
| Incidence of cardiovascular events within 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of moderate-to-severe pain within 72 hours after surgery | Moderate-to-severe pain is defined as a NRS pain score of 4 or higher at any timpoint. | Up to 72 hours after surgery |
| The proportion of patients receiving rescue analgesics within 72 hours after surgery. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong-Xin Wang, MD, PhD | Contact | 010-83572784 | wangdongxin@hotmail.com | |
| Zhen Zhang, MD | Contact | +86 13681035526 | zhangzhen1st@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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|
| 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. |
|
Cardiovascular events includes myocardial injury, non-fatal cardiac arrest, and all-cause death.
| Up to 7 days after surgery |
Rescue analgesics are defined as any analgesic drugs other than PCIA, including opioids, acetaminophen, non-steroid anti-inflammatory drugs, and other analgesics. |
| Up to 72 hours after surgery |
| Cumulative score of subjective sleep quality during the first 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). | Up to three nights after surgery |
| Quality of recovery 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). | At 24 hours after surgery |
| Incidence of acute kidney injuy within 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. | Up to 7 days after surgery |
| Length of hospital stay after surgery | Length of hospital stay after surgery | Up to 30 days after surgery |
| Incidence of complications within 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. | Up to 30 days after surgery |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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