Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Surgery
8 de agosto de 2026 atualizado por: Dong-Xin Wang, Peking University First Hospital
Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Surgery: a Randomized Trial
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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
148
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Dong-Xin Wang, MD, PhD
- Número de telefone: 010-83572784
- E-mail: wangdongxin@hotmail.com
Estude backup de contato
- Nome: Zhen Zhang, MD
- Número de telefone: +86 13681035526
- E-mail: zhangzhen1st@163.com
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100034
- Peking University First Hospital
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Contato:
- Dong-Xin Wang, MD, PhD
- Número de telefone: 010-83572784
- E-mail: wangdongxin@hotmail.com
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
|
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.
|
|
Comparador Ativo: 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.
|
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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The area under curve of pain intensity within 72 hours after surgery
Prazo: 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.
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Up to 72 hours after the surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Cumulative opioid consumption within 72 hours after surgery
Prazo: Up to 72 hours after the surgery
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Cumulative opioid consumption will be calculated as intravenous morphine equivalent dosage.
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Up to 72 hours after the surgery
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Incidence of cardiovascular events within 7 days after surgery
Prazo: Up to 7 days after surgery
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Cardiovascular events includes myocardial injury, non-fatal cardiac arrest, and all-cause death.
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Up to 7 days after surgery
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Tempo de internação após a cirurgia
Prazo: Até 30 dias após a cirurgia
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Tempo de internação após a cirurgia
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Até 30 dias após a cirurgia
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Incidence of moderate-to-severe pain within 72 hours after surgery
Prazo: Up to 72 hours after surgery
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Moderate-to-severe pain is defined as a NRS pain score of 4 or higher at any timpoint.
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Up to 72 hours after surgery
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Quality of recovery at 24 hours after surgery
Prazo: At 24 hours after surgery
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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).
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At 24 hours after surgery
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Incidence of complications within 30 days after surgery
Prazo: Up to 30 days after surgery
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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.
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Up to 30 days after surgery
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The proportion of patients receiving rescue analgesics within 72 hours after surgery.
Prazo: Up to 72 hours after surgery
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Rescue analgesics are defined as any analgesic drugs other than PCIA, including opioids, acetaminophen, non-steroid anti-inflammatory drugs, and other analgesics.
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Up to 72 hours after surgery
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Cumulative score of subjective sleep quality during the first three nights after surgery
Prazo: Up to three nights after surgery
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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).
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Up to three nights after surgery
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Incidence of acute kidney injuy within 7 days after surgery
Prazo: Up to 7 days after surgery
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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.
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Up to 7 days after surgery
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Dong-Xin Wang, MD, PhD, Peking University First Hospital
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Chahar P, Cummings KC 3rd. Liposomal bupivacaine: a review of a new bupivacaine formulation. J Pain Res. 2012;5:257-64. doi: 10.2147/JPR.S27894. Epub 2012 Aug 14.
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- Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de agosto de 2026
Conclusão Primária (Estimado)
1 de junho de 2028
Conclusão do estudo (Estimado)
1 de agosto de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
7 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de junho de 2026
Primeira postagem (Real)
12 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de agosto de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026R0311
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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