Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
10 de julho de 2017 atualizado por: Gary Peltz, Stanford University
The investigators hypothesize that perioperative administration of anakinra will reduce incisional pain by lowering the concentration of inflammatory mediators in surgical wounds.
This knowledge is important because it suggests a new, previously unexplored pharmacological target for the control of postoperative incisional pain.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Descrição detalhada
This study will test whether administration of anakinra, an IL-1 receptor antagonist, will decrease pain and improve wound healing in patients undergoing vascular or orthopedic surgical procedures.
The investigators will administer two doses of Anakinra via an injection under the skin, one dose one hour before surgery and a second dose on the first postoperative day (24 hours after surgery).
The investigators will remove fluid from the surgical incisions using a small plastic catheter placed under skin during surgery and measure the amounts of pain- causing inflammatory mediators.
The investigators will also measure the amount of pain the participant is experiencing using questions about pain intensity and by gently touching the incision to determine sensitivity of the incision site.
Tipo de estudo
Intervencional
Inscrição (Real)
13
Estágio
- Não aplicável
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.
Locais de estudo
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California
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Stanford, California, Estados Unidos, 94305
- Stanford Hospital and Clinics
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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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
-Patients 18 years of age and older presenting to the Stanford Preoperative Evaluation Clinic prior to elective orthopedic surgical procedures or elective vascular surgical procedures not involving the abdominal aorta or carotid arteries.
Exclusion Criteria:
Patients will be excluded from participation if they have one or more of the following conditions:
- Evidence of active local or systemic infection as demonstrated by fever, leukocytosis (white blood cell count > 11,000/ul), productive cough, new infiltrate on chest x-ray, or purulent drainage from any source
- End-stage renal disease
- A history of diabetic neuropathy
- A malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the previous 5 years
- Leukopenia (white blood cell count < 2,000/ul)
- Thrombocytopenia (platelet count < 100,000/ul)
- Abnormal liver function test result (aspartate aminotransferase or alanine aminotransferase level ≥1.5-fold the upper limit of normal)
- A history or infection with tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
- Pregnant or breastfeeding
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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Comparador Ativo: Anakinra
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
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An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
Outros nomes:
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Comparador de Placebo: Saline injection
Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
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An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
Outros nomes:
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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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Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra.
Prazo: Up to 72 hours following surgery
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Tissue samples were collected at the surgical wound site at 3 time points during the 1st 72 hours following surgery.
Tissue samples from subjects receiving placebo, and subjects receiving anakinra injections pre, and post op were analyzed for IL-1
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Up to 72 hours following surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery
Prazo: Up to 72 hours following surgery
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Analgesic consumption is reported as the count of participants receiving each analgesic type. Comparisons between the placebo and active drug groups were made at the conclusion of the study. PCA/IV: Patient controlled Analgesia/ Intravenous |
Up to 72 hours following surgery
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Post-operative Pain Intensity
Prazo: Up to 72 hours following surgery
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Pain was measured on Day 1 and day 2 following surgery using a VAS scale at rest and on stimulation with Visual Analog Scale (VAS) of 1-10 (1=no pain and 10=worst pain)
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Up to 72 hours following surgery
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Count of Participants Experiencing Wound Infection in the Study From Surgery Till the Time of Discharge From the Hospital
Prazo: Up to 72 hours following surgery plus 3 weeks follow-up
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Evaluation of the surgical wound for symptoms of wound infection was made every day during hospitalization.
Records from the first post-operative clinic visit were also evaluated for evidence of wound infection.
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Up to 72 hours following surgery plus 3 weeks follow-up
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Count of Participants With Venous Thrombosis After Surgery During Hospitalization
Prazo: Up to 72 hours following surgery plus 3 weeks follow-up
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Evaluation of the surgical wound for symptoms of venous thrombosis was made every day during hospitalization.
Records from the first post-operative clinic visit were also evaluated for evidence of venous thrombosis.
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Up to 72 hours following surgery plus 3 weeks follow-up
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Assess Rates of Wound Dehiscence
Prazo: Up to 72 hours following surgery plus 3 weeks follow-up
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Evaluation of the surgical wound for symptoms of wound dehiscence was made every day during hospitalization.
Records from the first post-operative clinic visit were also evaluated for evidence of wound dehiscence.
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Up to 72 hours following surgery plus 3 weeks follow-up
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Total Length of Hospital Stay
Prazo: Up to approximately 5 days maximum (admittance to discharge)
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Total length of hospital stay for patients enrolled in the study.
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Up to approximately 5 days maximum (admittance to discharge)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Robert L Lobato, MD, Stanford U
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
1 de outubro de 2011
Conclusão Primária (Real)
1 de maio de 2013
Conclusão do estudo (Real)
1 de junho de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
1 de novembro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de novembro de 2011
Primeira postagem (Estimativa)
8 de novembro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de agosto de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de julho de 2017
Última verificação
1 de julho de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SU-10312011-8587
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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