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

2020년 11월 15일 업데이트: 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).

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

297

단계

  • 2 단계
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: (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
의약품: EXPAREL 67 mg
5 mL EXPAREL expanded with 15 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty
다른 이름들:
  • Bupivacaine liposome injectable suspension 67 mg/5 mL
실험적: (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
의약품: EXPAREL 133 mg
10 mL EXPAREL expanded with 10 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty
다른 이름들:
  • Bupivacaine liposome injectable suspension 133 mg/10 mL
실험적: (Part 1) EXPAREL 266 mg
20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
의약품: EXPAREL 266 mg
20 mL EXPAREL as single-injection femoral nerve block prior to total knee arthroplasty
다른 이름들:
  • Bupivacaine liposome injectable suspension 266 mg/20 mL
위약 비교기: (Part 1) Placebo
20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
의약품: Placebo
Normal saline 20 mL as single-injection femoral nerve block prior to total knee arthroplasty
다른 이름들:
  • Preservative-free normal saline.
실험적: (Part 2) EXPAREL 266 mg
20 mL EXPAREL (bupivacaine liposome injectable suspension) as single-injection femoral nerve block ≤2 h preoperatively
의약품: EXPAREL 266 mg
20 mL EXPAREL as single-injection femoral nerve block prior to total knee arthroplasty
다른 이름들:
  • Bupivacaine liposome injectable suspension 266 mg/20 mL
위약 비교기: (Part 2) Placebo
20 mL normal saline as single-injection femoral nerve block ≤2 h preoperatively
의약품: Placebo
Normal saline 20 mL as single-injection femoral nerve block prior to total knee arthroplasty
다른 이름들:
  • Preservative-free normal saline.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Area Under the Curve (AUC) of Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Total Postsurgical Opioid Consumption Through 72 Hours
기간: 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
기간: 0-72 hours
Time to first opioid rescue medication consumed through 72 hours
0-72 hours

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pacira Pharmaceuticals, Inc

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2012년 9월 1일

기본 완료 (실제)

2013년 12월 1일

연구 완료 (실제)

2013년 12월 1일

연구 등록 날짜

최초 제출

2012년 9월 7일

QC 기준을 충족하는 최초 제출

2012년 9월 7일

처음 게시됨 (추정)

2012년 9월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 12월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 11월 15일

마지막으로 확인됨

2020년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 402-C-323

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

수술 후 통증에 대한 임상 시험

EXPAREL 67 mg에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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CROs in Mali

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다