Does Adding Lidocaine to Corticosteroid Injections Reduce Pain Intensity in Hand Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire (PHQ 2)
研究概览
简要总结
The purpose of this study was to determine whether adding Lidocaine to Corticosteroid injections reduce pain intensity in hand surgery.
详细描述
There is a lack of evidence about the use of lidocaine injection as an addition to steroids against pain during injections. Adding lidocaine adds to the volume of the injection, which might increase pain. It's possible that injecting cortisone without any lidocaine would be more comfortable than with lidocaine.
The aim of this randomized controlled trial is to assess the difference in pain intensity (during the injection and 4 hours later) between patients receiving a corticosteroid injection with or without lidocaine in patients with a hand condition. Secondarily, the aim of this study is to assess factors independently associated with pain intensity, satisfaction with the visit, and perceived empathy.
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
- Double (Participant, Care Provider)
盲法说明
To make this a double-blind study, the medical assistant will put a piece of tape around the syringe to cover up the volume.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients offered a steroid injection in a hand surgeon's office
- •Aged 18-89 years
- •English speaking patients
- •Able to provide informed consent
- •Exclusion criteria:
- •Non-English/Spanish speakers
排除标准
- 未提供
研究组 & 干预措施
Corticosteroid with Lidocaine
The group with the lidocaine will get a combined injection with a steroid and lidocaine. The dosages depend on the disease. The steroid dosage will be the same as for the group without lidocaine.
- Trigger finger/De Quervain's tenosynovitis/Tendonitis: 20mg kenalog (0.5mL of kenalog 40mg/mL suspension) + 5mg lidocaine (0,5mL 10mg/mL lidocaine solution)
- Carpal tunnel injections: 6mg betamethasone (1mL of betamethasone 6mg/mL suspension) + 20mg lidocaine (2mL 10mg/mL lidocaine solution)
- CMC/Basal joint arthritis: 3mg betamethasone (0.5mL of betamethasone 6mg/mL suspension) + 5mg lidocaine (0,5mL 10mg/mL lidocaine solution)
干预措施: Lidocaine (Drug)
Corticosteroid with Lidocaine
The group with the lidocaine will get a combined injection with a steroid and lidocaine. The dosages depend on the disease. The steroid dosage will be the same as for the group without lidocaine.
- Trigger finger/De Quervain's tenosynovitis/Tendonitis: 20mg kenalog (0.5mL of kenalog 40mg/mL suspension) + 5mg lidocaine (0,5mL 10mg/mL lidocaine solution)
- Carpal tunnel injections: 6mg betamethasone (1mL of betamethasone 6mg/mL suspension) + 20mg lidocaine (2mL 10mg/mL lidocaine solution)
- CMC/Basal joint arthritis: 3mg betamethasone (0.5mL of betamethasone 6mg/mL suspension) + 5mg lidocaine (0,5mL 10mg/mL lidocaine solution)
干预措施: Corticoids (Drug)
Corticosteroid without Lidocaine
The group without the lidocaine will get an injection with only steroids. The steroid dosage depends on the disease and will be the same as for the group with the lidocaine:
- Trigger finger/De Quervain's tenosynovitis/Tendonitis: 20mg kenalog (0,5mL of kenalog 40mg/mL suspension)
- Carpal tunnel injections: 6mg betamethasone (1mL of betamethasone 6mg/mL suspension)
- CMC/Basal joint arthritis: 3mg betamethasone (0,5mL of betamethasone 6mg/mL suspension)
干预措施: Corticoids (Drug)
结局指标
主要结局
Patient Health Questionnaire (PHQ 2)
时间窗: through study completion, an average of 6 weeks
a 2 item questionnaire measuring depression symptoms with a range of 0(no depression symptoms 0 to 6(maximum depression symptoms)
Pain Self-efficacy Questionnaire (PSEQ 2)
时间窗: through study completion, an average of 6 weeks
A measure of effective coping strategies with a range of 0(no coping strategy) to 12(maximum coping strategies)
Pain intensity during injection
时间窗: During Injection
11-point ordinal scale, with 0 for no pain at all and 10 for worst pain ever
Pain Catastrophizing Scale (PCS 4)
时间窗: through study completion, an average of 6 weeks
A 4 item questionnaire with a range of 0(no pain catastrophizing thoughts) to 16(maximum pain catastrophizing thoughts)
次要结局
- Pain intensity 4 hours after injection(4 hours after injection)
- Pain intensity 5 minutes after injection(5 minutes after injection)
研究者
David Ring
David Ring, MD, PhD Associate Dean for Comprehensive Care, Professor of Surgery and Psychiatry
University of Texas at Austin