Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Pain Score 8 Hours Post-operativley
研究概览
简要总结
Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as effective as this solution plus ropivacaine administered intra-articularly for twenty-four hours.
Three groups were assigned random patients, each group provided a different method of pain medication in order to determine the effectiveness of each treatment.
详细描述
Arthroscopic knee patients were randomized to 1 of 3 groups. A) 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; B) an identical solution plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour; C) an identical solution and no pain pump. Pain level, the amount of pain medication used and time to discharge were recorded. Clinical and radiographic evaluation was performed at nine months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects who underwent:
- •knee arthroscopy + synovectomy
- •knee arthroscopy + partial or complete meniscectomy
- •knee arthroscopy + chondroplasty
- •knee arthroscopy + microfracture
- •knee arthroscopy + autologous osteoarticular transplantation
排除标准
- •A surgical procedure that required an incision other then an arthroscopic portal
- •A surgical procedure within the same joint within ninety days
- •A acute or chronic knee infection
- •Any diagnosis of complex regional pain syndrome
- •A known allergy to one of the study drugs
- •A documented history of narcotic use
- •A score of less than two standard deviation on the SF-12 mental component
- •Any major systemic or cardiac illness (heart failure, uncontrolled angina, bifascicular blocks, renal insufficiency, or liver disease)
- •Under the age of eighteen years
研究组 & 干预措施
pain pump , injectable medication
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour;
干预措施: pain pump containing ropivacaine (Device)
saline pain pump , injectable medication
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
干预措施: saline pain pump with injectable medication (Device)
injectable medication only
30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected and no pain pump.
干预措施: ropivacaine, ketorolac , morphine sulfate (Drug)
结局指标
主要结局
Pain Score 8 Hours Post-operativley
时间窗: 8 hours post surgery
Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Pain Scale
时间窗: 72 hours post surgery
Visual Analog Scale. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
次要结局
- Number of Narcotic Pills and Morphine Sulfate Used(Post surgery day 3)