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Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia Following Total Knee Arthroplasty

15 de novembro de 2020 atualizado por: Pacira Pharmaceuticals, Inc

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Single Injection Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Total Knee Arthroplasty

The primary objectives of Part 1 are to (1) evaluate three dose levels of liposome bupivacaine versus placebo with respect to the magnitude and duration of the analgesic effect achieved following single dose injection femoral nerve block with liposome bupivacaine, and (2) select a single therapeutic dose of liposome bupivacaine from the three dose levels to be tested in Part 2.

Part 2: The primary objective of Part 2 is to compare the magnitude and duration of the analgesic effect of single injection femoral nerve block of a single dose level of liposome bupivacaine (selected from Part 1) with placebo (preservative-free normal saline).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

This is a Phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled, dose-ranging study in subjects undergoing primary unilateral total knee arthroplasty (TKA) under general or spinal anesthesia. Note: Bupivacaine cannot be used as the spinal anesthetic.

Part 1 During Part 1 of the study, approximately 100 subjects (25 per treatment arm) will be randomized to receive a single dose injection femoral nerve block with either one of three doses of liposome bupivacaine (67, 133, or 266 mg) or placebo in 20 mL under ultrasound guidance. Preservative-free normal saline will be added to the 67 mg and 133 mg doses of study drug to achieve a volume of 20 mL.

Part 2 In Part 2 of the study, approximately 180 subjects (randomized 1:1, resulting in approximately 90 liposome bupivacaine subjects and 90 placebo subjects) will receive a single dose injection femoral nerve block with the selected dose level of liposome bupivacaine (i.e., 67, 133, or 266 mg) or placebo in 20 mL under ultrasound guidance.

Tipo de estudo

Intervencional

Inscrição (Real)

297

Estágio

  • Fase 2
  • Fase 3

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

  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35216
        • ACHIEVE CLINICAL RESEARCH LLC 2017 Canyon Road Suite 41
      • Mobile, Alabama, Estados Unidos, 36608
        • HORIZON RESEARCH GROUP INC 3610 Springhill Memorial Dr. N
      • Mobile, Alabama, Estados Unidos, 36660
        • Veritas Research, LLC
      • Sheffield, Alabama, Estados Unidos, 35660
        • SHOALS MEDICAL TRIALS INC. 1300 S Montgomery Ave
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85023
        • PHOENIX ORTHOPAEDIC SURGEONS 2525 W. Greenway Road Suite 114
    • California
      • Laguna Hills, California, Estados Unidos, 92653
        • ALLIANCE RESEARCH CENTERS 24411 Health Center Drive Suite 350
      • San Bernardino, California, Estados Unidos, 92508
        • ORTHOPADIC SURGERY Loma Linda University Health Care Dept. Pf Orthopaedic Surgery 250 East Caroline Street Suite A
      • San Diego, California, Estados Unidos, 92103
        • University of California, San Diego
      • San Diego, California, Estados Unidos, 92130
        • Ilfeld, Brian (Thornton) UNIVERSITY OF CALIFORNIA, SAN DIEGO 10610 Hunters Glen Drive
    • Florida
      • DeLand, Florida, Estados Unidos, 32720
        • FLORIDA RESEARCH ASSOCIATES, LLC / FLORIDA ORTHOPAEDIC ASSOCIATES 740 W. Plymouth Ave
      • Miami, Florida, Estados Unidos, 33136
        • JACKSON MEMORIAL HOSPITAL UNVERSITY OF MIAMI 1611 Nw. 12th Ave C300
      • Pensacola, Florida, Estados Unidos, 32504
        • PENSACOLA RESEARCH CONSULTANTS,INC 5149 N.9th Avenue Suite 241
      • Sunrise, Florida, Estados Unidos, 33323
        • SHERIDAN CLINICAL RESEARCH, INC. 1613 N. Harrison Parkway Building C Suite 200
      • Tamarac, Florida, Estados Unidos, 33321
        • PHOENIX CLINICAL RESEARCH,LLC 7171 N. University Drive Suite 100
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • UNIVERSITY OF KANSAS HOSPITAL & MEDICAL CENTER Dept. Of Anesthesiology 3901 Rainbow Blvd. Ms 1034
    • Michigan
      • Troy, Michigan, Estados Unidos, 48085
        • BEAUMONT HEALTH SYSTEM 44201 Dequindre Road Suite Pob 120
    • New Jersey
      • Camden, New Jersey, Estados Unidos, 08103
        • COOPER UNIVERSITY HOSPITAL 1 Cooper Plaza 202 Dorrance Building
      • Newark, New Jersey, Estados Unidos, 07101
        • UNIVERSITY OF MEDICINE AND DENSITRY OF NEW JERSEY/NEW JERSEY MEDICAL SCHOOL 185 South Orange Ave. Department of Anesthesiology - MSB E538
    • New York
      • Mount Kisco, New York, Estados Unidos, 10549
        • NORTHERN WESTCHESTER HOSPTIAL Department Of Clinical Trials 400 East Main St.
      • New York, New York, Estados Unidos, 10025
        • ST. LUKE-ROOSEVELT HOSPITAL CENTER Dept. Of Anesthesiology 1111 Amsterdam Ave. Travis Bld. 7
      • New York, New York, Estados Unidos, 10065
        • INSALL-SCOTT-KELLY INSTITUTE 210 East 64th Street
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL Department Of Anesthesiology 101 Manning Drive N0021, Cb 7010
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44111
        • CLEVELAND CLINIC FAIRVIEW HOSPTIAL 1801 Lorain Avenue
      • Cleveland, Ohio, Estados Unidos, 44195
        • CLEVELAND CLINIC 9500 Euclid Ave P-77
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • PENN STATE MILTON S. HERSHEY MEDICAL CENTER H187,500 University Drive
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • THOMAS JEFFERSON UNIVERSITY Dept. Of Anesthesiology 111 S. 11th Street Suite G 8490
      • Pittsburgh, Pennsylvania, Estados Unidos, 15232
        • UPMC PRESBYTERIAN SHADYSIDE/ DEPT. OF ANESTHESIOLOGY POSNER PAIN CENTER 532 South Aiken Avenue Suite 407
    • Texas
      • Galveston, Texas, Estados Unidos, 77551
        • UNIVERSITY OF TEXAS MEDICAL BRANCH Dept. Chairman, Orthopedic Surgery & Rehabilitation 2.316 Rebecca Sealy Hospital 301 University Blvd.
      • Houston, Texas, Estados Unidos, 77024
        • RESEARCH CONCEPTS,GP LLC 921 Gessner Rd. Anesthesia Dept., Classroom F
      • Nassau Bay, Texas, Estados Unidos, 77058
        • CHRISTUS ST. JOHN HOSPITAL 18300 St. John Dr., 2nd Floor, Surgery

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:

  1. Male or female, >=18 years of age.
  2. Scheduled to undergo primary unilateral TKA under general or spinal anesthesia.
  3. American Society of Anesthesiologists (ASA) Physical Status 1, 2, or 3.
  4. Able to demonstrate motor function by performing a 20-meter walk, unassisted with the optional use of a 4-legged walker, and sensory function by exhibiting sensitivity to cold.
  5. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

  1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. Female subjects must be surgically sterile, at least 2 years menopausal, or using an acceptable method of birth control.

    If of childbearing potential, must have a documented negative pregnancy test within 24 hours before surgery.

  2. Planned concurrent surgical procedure (e.g., bilateral TKA).

  3. Use of any of the following medications within the times specified before surgery:

    long-acting opioid medication, NSAIDs, aspirin (except for low-dose aspirin used for cardioprotection) or acetaminophen within 3 days, or and any opioid medication within 24 hours.

  4. Concurrent painful physical condition or concurrent surgery that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the surgical site administered study treatment, and which may confound the postsurgical assessments (e.g., significant pain from other joints including the non-index knee joint, chronic neuropathic pain, prior contralateral TKA, concurrent foot surgery).
  5. Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinepherine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®).
  6. Current use of systemic glucocorticosteroids within 1 month of enrollment in this study.
  7. Body weight < 50 kilograms (110 pounds) or a body mass index ≥ 40 kg/m2.
  8. Contraindication to hydromorphone, oxycodone, or bupivacaine.
  9. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
  10. Previous participation in a liposome bupivacaine study.
  11. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  12. Failure to pass the urine drug screen.
  13. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance.
  14. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
  15. Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postsurgical course.
  16. Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures.
  17. Subjects who are planned to receive Entereg® (alvimopan).
  18. Subjects who will receive prophylactic antiemetics or planned postsurgical antiemetics given without regard to the subject's emesis needs.
  19. Use of dexmedetomidine HCl (Precedex®) within 3 days of surgery.

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
Experimental: (Part 1) EXPAREL 67 mg
5 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 15 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
Medicamento: EXPAREL 67 mg
5 mL EXPAREL expanded with 15 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty
Outros nomes:
  • Bupivacaine liposome injectable suspension 67 mg/5 mL
Experimental: (Part 1) EXPAREL 133 mg
10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
Medicamento: EXPAREL 133 mg
10 mL EXPAREL expanded with 10 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty
Outros nomes:
  • Bupivacaine liposome injectable suspension 133 mg/10 mL
Experimental: (Part 1) EXPAREL 266 mg
20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
Medicamento: EXPAREL 266 mg
20 mL EXPAREL as single-injection femoral nerve block prior to total knee arthroplasty
Outros nomes:
  • Bupivacaine liposome injectable suspension 266 mg/20 mL
Comparador de Placebo: (Part 1) Placebo
20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
Medicamento: Placebo
Normal saline 20 mL as single-injection femoral nerve block prior to total knee arthroplasty
Outros nomes:
  • Preservative-free normal saline.
Experimental: (Part 2) EXPAREL 266 mg
20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
Medicamento: EXPAREL 266 mg
20 mL EXPAREL as single-injection femoral nerve block prior to total knee arthroplasty
Outros nomes:
  • Bupivacaine liposome injectable suspension 266 mg/20 mL
Comparador de Placebo: (Part 2) Placebo
20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
Medicamento: Placebo
Normal saline 20 mL as single-injection femoral nerve block prior to total knee arthroplasty
Outros nomes:
  • Preservative-free normal saline.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Area Under the Curve (AUC) of Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours
Prazo: 0-72 hours
AUC of NRS-R pain intensity scores through 72 hours. Pain intensity scores were measured on an 11-point NRS (0=no pain and 10=worst possible pain)
0-72 hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Total Postsurgical Opioid Consumption Through 72 Hours
Prazo: 0-72 hours
Total postsurgical opioid consumption of opioid rescue pain medication (converted to IV morphine equivalents) through 72 hours
0-72 hours
Time to First Opioid Rescue Through 72 Hours
Prazo: 0-72 hours
Time to first opioid rescue medication consumed through 72 hours
0-72 hours

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Pacira Pharmaceuticals, Inc

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 setembro de 2012

Conclusão Primária (Real)

1 de dezembro de 2013

Conclusão do estudo (Real)

1 de dezembro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

7 de setembro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de setembro de 2012

Primeira postagem (Estimativa)

11 de setembro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de dezembro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de novembro de 2020

Última verificação

1 de novembro de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 402-C-323

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

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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