Treatment of Postoperative Pain After Shoulder Surgery. Ultrasound-guided Block of the Axillary and Suprascapular Nerves (Selective Shoulder Block) Versus Ultrasound-guided Interscalene Brachial Plexus Block: An Observer-blinded RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain Score as measured by Numeric Rating Scale
研究概览
简要总结
This is a randomised, observer-blinded trial to compare selective shoulder block with interscalene block. Both blocks will be placed using an ultra-sound guided technique.
Primary outcome measures will be postoperative pain scores and use of rescue opioids. Secondary outcome measures will be pre- and postoperative occurence of motor deficit of the arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric rating scale and overall satisfaction with pain therapy as measured by the International Pain Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very satisfied).
Primary and secondary outcome measures will be assessed during the first 24hours after surgery (assessment in the postanesthetic care unit (PACU) directly after admission and before discharge and in the surgical ward at 4, 8 and 24 hours after surgery).
Overall satisfaction with pain therapy will be assessed 48hours after surgery.
An interscalene block is a block of the plexus brachialis in the interscelene triangle (by injecting a local anesthetic around the nerve plexus).
A selective shoulder block is a block of the suprascapular and axillary nerves (by injecting a local anesthetic around these nerves).
详细描述
This is a randomised, observer-blinded trial to compare selective shoulder block with interscalene block.
The goal of this study is to compare ultrasound-guided selective shoulder block (regional anesthesia of the suprascapular and axillary nerves) with ultrasound-guided interscalene block after arthroscopic shoulder surgery.
More specific, this study is designed to compare postoperative pain scores, use of opioids, pre- and postoperative occurence of motor deficit of the arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric rating scale and overall satisfaction as measured by the International Pain Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very satisfied).
Primary and secondary outcome measures will be assessed during the first 24hours after surgery (assessment in the postanesthetic care unit (PACU) directly after admission and before discharge and in the surgical ward at 4, 8 and 24 hours after surgery).
Overall satisfaction with pain therapy will be assessed 48hours after surgery.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective arthroscopic shoulder surgery
- •elective hospital admission for one night
- •age > 18 years and < 75 years
- •American Society of Anesthesiologists (ASA) physical status classification 1, 2 of 3.
排除标准
- •pregnancy
- •severe obesity ( BMI > 35)
- •severe COPD (Gold≥ 3) or restrictive (FEV1 < 50%) lungdisease
- •coagulation disorders
- •diabetes mellitus
- •previous injury or surgery of the involved shoulder
- •pre-existing neuropathy or myopathy of the involved arm
- •allergy or contra-indication for the medication used in the study
- •preoperative use of opioids
- •infection at the puncture site
- •inability to understand or speak Dutch
- •inability to understand the PCIA system
- •inability to understand the NRS pain score system
- •refusal to participate in the study
结局指标
主要结局
Pain Score as measured by Numeric Rating Scale
时间窗: 24hours
Use of piritramide as documented by the PCIA (patient controlled intravenous analgesia) system
时间窗: 24hours
次要结局
- Overall satisfaction as measured by the International Pain Outcomes questionnaire(48 hours)
- Subjective feeling of dyspnea as measured by a numeric rating scale(24hours)
- Motor deficit after nerve block as measured by Medical Research Council scale(24hours)
- Quality of sleep in the first night after surgery as measured by a numeric rating scale(24hours)
研究者
Stessel Björn
MD
Jessa Hospital