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

15 novembre 2020 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

297

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: (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
Altri nomi:
  • Bupivacaine liposome injectable suspension 67 mg/5 mL
Sperimentale: (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
Altri nomi:
  • Bupivacaine liposome injectable suspension 133 mg/10 mL
Sperimentale: (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
Altri nomi:
  • Bupivacaine liposome injectable suspension 266 mg/20 mL
Comparatore placebo: (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
Altri nomi:
  • Preservative-free normal saline.
Sperimentale: (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
Altri nomi:
  • Bupivacaine liposome injectable suspension 266 mg/20 mL
Comparatore placebo: (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
Altri nomi:
  • Preservative-free normal saline.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Area Under the Curve (AUC) of Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total Postsurgical Opioid Consumption Through 72 Hours
Lasso di tempo: 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
Lasso di tempo: 0-72 hours
Time to first opioid rescue medication consumed through 72 hours
0-72 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pacira Pharmaceuticals, Inc

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2012

Completamento primario (Effettivo)

1 dicembre 2013

Completamento dello studio (Effettivo)

1 dicembre 2013

Date di iscrizione allo studio

Primo inviato

7 settembre 2012

Primo inviato che soddisfa i criteri di controllo qualità

7 settembre 2012

Primo Inserito (Stima)

11 settembre 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 dicembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 novembre 2020

Ultimo verificato

1 novembre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 402-C-323

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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