The Analgesic Effect of Continuous Subacromial Bupivacaine Infusion After Arthroscopic Shoulder Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The consumption of analgesics (oxycodone)
研究概览
简要总结
The investigators wanted to re-evaluate the effects of subacromial bupivacaine infusion after shoulder arthroscopy with standard surgical techniques, including rotator cuff operations. The investigators hypothesized that patients having 5.0 mg/ml bupivacaine infusion at a rate of 2 ml/h subacromially would need less opioids than patients receiving a placebo infusion.
详细描述
Shoulder surgery has become a routine outpatient procedure. Previously shoulder surgery was associated with intense, occasionally severe postoperative pain and hence considerable use of opioids. Also arthroscopic shoulder surgery, especially rotator cuff procedures, may cause significant pain resulting sometimes in inpatient admission. Subacromial local anaesthetic infusion as a part of a multimodal approach is one commonly used modality to pain relief after shoulder surgery. Nevertheless, it has been criticized recently for its poor benefits and possible adverse effects. On the whole, the scientific evidence of the advantages of local anaesthetic infusions is inconclusive.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subacromial impingement disease
- •scheduled for an elective arthroscopic surgery
排除标准
- •liver disease
- •renal impairment
- •psychiatric disorder
- •alcohol abuse
- •obesity (a body mass index of > 35 kg/m2)
- •allergies to the drugs used in the study
研究组 & 干预措施
bupivacaine
a continuous flow of 5 mg/ml bupivacaine 2 ml/h 48 h
干预措施: bupivacaine (Drug)
saline
saline 9 mg/ml infusion 2 ml/h 48 h
干预措施: bupivacaine (Drug)
结局指标
主要结局
The consumption of analgesics (oxycodone)
时间窗: It was recorded on a daily basis during the first three days
次要结局
- The intensity of pain(During the study the pain assessments were recorded 15 min before operation, 15 min, 6, 12 and 18 h after the beginning of the operation and on the first and third postoperative day)