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

15 november 2020 bijgewerkt door: 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).

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

297

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: (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
5 mL EXPAREL expanded with 15 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty
Andere namen:
  • Bupivacaine liposome injectable suspension 67 mg/5 mL
Experimenteel: (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
10 mL EXPAREL expanded with 10 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty
Andere namen:
  • Bupivacaine liposome injectable suspension 133 mg/10 mL
Experimenteel: (Part 1) EXPAREL 266 mg
20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
20 mL EXPAREL as single-injection femoral nerve block prior to total knee arthroplasty
Andere namen:
  • Bupivacaine liposome injectable suspension 266 mg/20 mL
Placebo-vergelijker: (Part 1) Placebo
20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
Normal saline 20 mL as single-injection femoral nerve block prior to total knee arthroplasty
Andere namen:
  • Preservative-free normal saline.
Experimenteel: (Part 2) EXPAREL 266 mg
20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
20 mL EXPAREL as single-injection femoral nerve block prior to total knee arthroplasty
Andere namen:
  • Bupivacaine liposome injectable suspension 266 mg/20 mL
Placebo-vergelijker: (Part 2) Placebo
20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
Normal saline 20 mL as single-injection femoral nerve block prior to total knee arthroplasty
Andere namen:
  • Preservative-free normal saline.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Area Under the Curve (AUC) of Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total Postsurgical Opioid Consumption Through 72 Hours
Tijdsspanne: 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
Tijdsspanne: 0-72 hours
Time to first opioid rescue medication consumed through 72 hours
0-72 hours

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2012

Primaire voltooiing (Werkelijk)

1 december 2013

Studie voltooiing (Werkelijk)

1 december 2013

Studieregistratiedata

Eerst ingediend

7 september 2012

Eerst ingediend dat voldeed aan de QC-criteria

7 september 2012

Eerst geplaatst (Schatting)

11 september 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 december 2020

Laatste update ingediend die voldeed aan QC-criteria

15 november 2020

Laatst geverifieerd

1 november 2020

Meer informatie

Termen gerelateerd aan deze studie

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op EXPAREL 67 mg

3
Abonneren