Effective Pain Management of Continuous Versus Single Shot Injection Interscalene Block During Shoulder Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Pain Score Measure
研究概览
简要总结
Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of postoperative pain. Adequate management of pain after surgery is necessary not only to improve the patient's wellbeing but also to facilitate recovery. Several regional anesthesia techniques are available to combat postoperative pain in the shoulder replacement surgery patient, however, which method provides superior pain relief remains unknown. The purpose of this study is to examine the effectiveness of a continuous interscalene block versus a single shot interscalene block for postoperative pain relief in the shoulder replacement patient.
Patients undergoing shoulder replacement surgery will experience more effective pain relief with a continuous interscalene block versus and single shot interscalene block.
详细描述
This is a prospective randomized controlled trial. 76 patients receiving either primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement will be randomized to a regional anesthesia technique as part of their surgical procedure. 38 patients will receive a single shot interscalene block containing ropivicaine and 38 patients will receive a continuous interscalene block containing ropivicaine.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical candidate for primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement
- •patient must be 18 years or older and willing to sign and date an Institutional Review Board informed consent form, and
- •must be able to understand and agree to follow study protocol.
排除标准
- •severe bronchopulmonary disease,
- •oxygen dependent,
- •existing nerve injury,
- •BMI > 40,
- •coagulation disorders,
- •allergy to ropivicaine,
- •history of drug or alcohol abuse,
- •American Academy of Anaesthesiologists physical status classification > lll,
- •pregnant women.
研究组 & 干预措施
Ropivacaine Single Shot Block
Single Shot Interscalene block patients will receive a single shot of 30ml of 0.5% Ropivacaine prior to surgery
干预措施: Ropivacaine (Drug)
Ropivacaine Continuous block
Continuous Interscalene block patients will receive a shot of up to 30ml of 0.5% Ropivacaine and then a catheter is placed. The catheter is secured with Dermabond and Tegaderm. Once surgery is complete, the catheter is connected to a pain ball system which holds 400ml of 0.2% Ropivacaine local anesthetic. The rate is locked in at 8ml/hr. Catheter is pulled once the pain ball is empty.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Pain Score Measure
时间窗: participants will be followed for the duration of the hospital stay, an expected average of 3 days
Patients will be assessed for pain levels by visual analog scale while in the hospital per nursing protocol. Electronic Medical Record will be used to acquire pain scores.
次要结局
- Morphine Sulfate Equivalence consumption(participants morphine sulfate consumption will be gathered for the duration of the hospital stay, an expected average of 3 days)
- Pain control Satisfaction Score(10 day post operative)