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

15 de noviembre de 2020 actualizado 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).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

297

Fase

  • Fase 2
  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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
Droga: EXPAREL 67 mg
5 mL EXPAREL expanded with 15 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty
Otros nombres:
  • 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
Droga: EXPAREL 133 mg
10 mL EXPAREL expanded with 10 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty
Otros nombres:
  • 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
Droga: EXPAREL 266 mg
20 mL EXPAREL as single-injection femoral nerve block prior to total knee arthroplasty
Otros nombres:
  • Bupivacaine liposome injectable suspension 266 mg/20 mL
Comparador de placebos: (Part 1) Placebo
20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
Droga: Placebo
Normal saline 20 mL as single-injection femoral nerve block prior to total knee arthroplasty
Otros nombres:
  • 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
Droga: EXPAREL 266 mg
20 mL EXPAREL as single-injection femoral nerve block prior to total knee arthroplasty
Otros nombres:
  • Bupivacaine liposome injectable suspension 266 mg/20 mL
Comparador de placebos: (Part 2) Placebo
20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
Droga: Placebo
Normal saline 20 mL as single-injection femoral nerve block prior to total knee arthroplasty
Otros nombres:
  • Preservative-free normal saline.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Area Under the Curve (AUC) of Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total Postsurgical Opioid Consumption Through 72 Hours
Periodo de tiempo: 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
Periodo de tiempo: 0-72 hours
Time to first opioid rescue medication consumed through 72 hours
0-72 hours

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pacira Pharmaceuticals, Inc

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2012

Finalización primaria (Actual)

1 de diciembre de 2013

Finalización del estudio (Actual)

1 de diciembre de 2013

Fechas de registro del estudio

Enviado por primera vez

7 de septiembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

7 de septiembre de 2012

Publicado por primera vez (Estimar)

11 de septiembre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de diciembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

15 de noviembre de 2020

Última verificación

1 de noviembre de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 402-C-323

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre EXPAREL 67 mg

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