무릎 골관절염에 대한 코르티코스테로이드 주사를 위한 최적의 마취제 (Injections)
무릎 골관절염에 대한 코르티코스테로이드 주사를 위한 최적의 마취제.
To evaluate pain relief from corticosteroid injection with and without anesthetic as well as with variable volume of anesthetic. Pain relief will be measured using the VAS pain score at the time of the injection as well as several time points following the injection to capture pain relief longevity. The investigators intend to evaluate how well the patients tolerate corticosteroid mixtures without anesthetic as well as with different volumes of anesthetic. Primary measure will be the time from procedure when postoperative status is considered success (as measured by global perceived improvement score).
연구 개요
상세 설명
Primary objective is to evaluate pain relief from corticosteroids, Kenalog without anesthetic as well as with different volumes of anesthetic. The investigators will measure the VAS pain score at the time of the injection as well as several time points following the injection. Additionally, the investigators will evaluate how long the injection provided pain relief for the patient.
The secondary intend is to evaluate how well the patients tolerate Kenalog mixtures without anesthetic as well as with different volumes of anesthetic by using the VAS pain scale.
The investigators hypothesize that patient with lower volume of injection will experience less pain during the procedure and that there will be no statistically significant difference in pain level between the study groups during the study period.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Florida
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Tampa, Florida, 미국, 33637
- Florida Orthopaedic Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients must be 18 years of age and be able to consent for themselves.
- OA grade Kellgren Lawrence Stage II or III.
- Diagnosis of primary osteoarthritis.
Exclusion Criteria:
- Patients with other forms of arthritis such as inflammatory arthritis.
- History of narcotic use for the past 6 months.
- Kellgren Lawrence arthritis grade 1 or 4.
- Pregnant women and prisoners.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Kenalog with 0ml bupivacaine
The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0ml of bupivacaine. The patients will be randomized into this group. |
Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.
다른 이름들:
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실험적: Kenalog with 4ml bupivacaine
The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,4ml of bupivacaine. The patients will be randomized into this group. |
Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.
다른 이름들:
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실험적: Kenalog with 0.25% bupivacaine
The intervention in this study is one intra-articular knee injection of synthetic corticosteroid (kenalog) and variable amount of anesthetic,0.25% of bupivacaine. The patients will be randomized into this group. |
Indications, relevant for this study include Kenalog injection for knee pain from osteoarthritis or inflammatory arthritis. A single injection to a patient who has no known allergies to anesthetic or corticosteroids would be administered during a scheduled clinical visit.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Injection for Knee Pain
기간: Prior to procedure (in office)
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Visual Analogue Scale (VAS) |
Prior to procedure (in office)
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Injection for Knee Pain
기간: Immediate post procedure (in office)
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Visual Analogue Scale (VAS) |
Immediate post procedure (in office)
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Injection for Knee Pain
기간: 2 minutes post procedure (in office)
|
Visual Analogue Scale (VAS) |
2 minutes post procedure (in office)
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Injection for Knee Pain
기간: Day 1 post procedure (phone interview)
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Visual Analogue Scale (VAS) |
Day 1 post procedure (phone interview)
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Injection for Knee Pain
기간: Day 14 post procedure (through EDC)
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Visual Analogue Scale (VAS) |
Day 14 post procedure (through EDC)
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Injection for Knee Pain
기간: Day 42 post procedure (in office)
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Visual Analogue Scale (VAS) |
Day 42 post procedure (in office)
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Injection for Knee Pain
기간: Day 84 post procedure (through EDC)
|
Visual Analogue Scale (VAS) |
Day 84 post procedure (through EDC)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessment of Knee Pain
기간: Immediate Post-op (in office)
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Global Perceived Improvement |
Immediate Post-op (in office)
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Assessment of Knee Pain
기간: Day 1 post procedure (phone interview)
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Global Perceived Improvement |
Day 1 post procedure (phone interview)
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Assessment of Knee Pain
기간: Day 42 post procedure (in office)
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Global Perceived Improvement |
Day 42 post procedure (in office)
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Assessment of Knee Pain
기간: Day 84 post procedure (through EDC)
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Global Perceived Improvement |
Day 84 post procedure (through EDC)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Medications
기간: Prior to procedure (in office)
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Review of Medications |
Prior to procedure (in office)
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Medications
기간: Day 1 post procedure (phone interview)
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Review of Medications |
Day 1 post procedure (phone interview)
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Medications
기간: Day 14 post procedure (through EDC)
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Review of Medications |
Day 14 post procedure (through EDC)
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Medications
기간: Day 42 post procedure (in office)
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Review of Medications |
Day 42 post procedure (in office)
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Medications
기간: Day 84 post procedure (through EDC)
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Review of Medications |
Day 84 post procedure (through EDC)
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Review of Adverse Events
기간: Immediate post procedure (in office)
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Any issues with procedure |
Immediate post procedure (in office)
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Review of Adverse Events
기간: Day 1 post procedure (phone interview)
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Any issues with procedure |
Day 1 post procedure (phone interview)
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Review of Adverse Events
기간: Day 42 post procedure (in office)
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Any issues with procedure |
Day 42 post procedure (in office)
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Review of Adverse Events
기간: Day 84 post procedure (through EDC)
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Any issues with procedure |
Day 84 post procedure (through EDC)
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Bedard NA, Dowdle SB, Anthony CA, DeMik DE, McHugh MA, Bozic KJ, Callaghan JJ. Response to Letter to the Editor on "The AAHKS Clinical Research Award: What Are the Costs of Knee Osteoarthritis in the Year Prior to Total Knee Arthroplasty?". J Arthroplasty. 2018 Jan;33(1):307. doi: 10.1016/j.arth.2017.10.002. Epub 2017 Oct 10. No abstract available.
- Blankstein M, Lentine B, Nelms NJ. Common Practices in Intra-Articular Corticosteroid Injection for the Treatment of Knee Osteoarthritis: A Survey of the American Association of Hip and Knee Surgeons Membership. J Arthroplasty. 2021 Mar;36(3):845-850. doi: 10.1016/j.arth.2020.09.022. Epub 2020 Oct 8.
- Grishko V, Xu M, Wilson G, Pearsall AW 4th. Apoptosis and mitochondrial dysfunction in human chondrocytes following exposure to lidocaine, bupivacaine, and ropivacaine. J Bone Joint Surg Am. 2010 Mar;92(3):609-18. doi: 10.2106/JBJS.H.01847.
- Smith MD, Wetherall M, Darby T, Esterman A, Slavotinek J, Roberts-Thomson P, Coleman M, Ahern MJ. A randomized placebo-controlled trial of arthroscopic lavage versus lavage plus intra-articular corticosteroids in the management of symptomatic osteoarthritis of the knee. Rheumatology (Oxford). 2003 Dec;42(12):1477-85. doi: 10.1093/rheumatology/keg398. Epub 2003 Jul 16.
- Parker RD, Streem K, Schmitz L, Martineau PA; Marguerite Group. Efficacy of continuous intra-articular bupivacaine infusion for postoperative analgesia after anterior cruciate ligament reconstruction: a double-blinded, placebo-controlled, prospective, and randomized study. Am J Sports Med. 2007 Apr;35(4):531-6. doi: 10.1177/0363546506296313. Epub 2007 Jan 23.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- PI_ PAL_V3_ 8
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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