Optimal Anesthetic for Corticosteroid Injections for Knee Osteoarthritis.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Injection for Knee Pain
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The PI standard of care is to offer patients who complain of knee pain a corticosteroids injection regardless of patient participation in a study. A consent will be obtained prior the injection by a trained/qualified team member. Subjects will be randomly allocated to groups by concealed allocation. Randomization sequence between three groups will be created using Excel and will be further stratified by sex within each block, to ensure even distribution. A set of numbered envelopes will be created, with each having one unique group assigned. A staff member will assign an envelope with group assignment upon consent and record envelope number ID. The ARNP will open an envelope, administer injection based on the group assigned. The ARNP will prepare the medication to maintain the double blinded aspect of the study. The ARNP is trained and experienced with injections and has giving injections for several years. She will not be involved in the evaluations of the patient pre/post injection.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •Pregnant women and prisoners.
研究组 & 干预措施
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.
干预措施: Kenalog with bupivacaine Injection (Drug)
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.
干预措施: Kenalog with bupivacaine Injection (Drug)
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.
干预措施: Kenalog with bupivacaine Injection (Drug)
结局指标
主要结局
Injection for Knee Pain
时间窗: Day 84 post procedure (through EDC)
Visual Analogue Scale (VAS)
次要结局
- Assessment of Knee Pain(Day 84 post procedure (through EDC))