Suprascapular Nerve Block as Postoperative Analgesia After Artroscopic Shoulder Surgery - a Randomized, Blinded, Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Visual analogue scale (VAS) score at rest at T½
研究概览
简要总结
The purpose of this randomized study is to examine the effect of a selective suprascapular nerve block on post operative pain after arthroscopic shoulder surgery. Half of the subjects will receive a active nerve block with Ropivacain. Half of the subjects will receive a placebo nerve block with saline.
详细描述
Postoperative pain management after arthroscopic shoulder surgery traditionally includes opioids and/or an interscalene brachial plexus block(IBPB). Opioid consumption often leads to unpleasant side effects including nausea, vomitting and sedation. IBPB offers very efficient pain relief but includes the discomfort of a paralyzed arm. Furthermore this approach often also leads to unilateral paresis of the phrenic nerve causing reduced respiratory capacity. The latter offering discomfort and a potential risk in patients with lung diseases or heavy overweight.
The suprascapular nerve is the most important nerve to the shoulder and a selective block of this nerve could offer a good pain relief without the mentioned side effects.
In this randomized study the investigators wish to examine the pain relieving effect of a selective block of the suprascapular nerve after arthroscopic shoulder surgery.
40 patients are randomized to a block of this nerve with either active drug (Ropivacaine) or placebo (Saline). All patients will get a PCA (Patient Controlled Analgesia) pump for administration of i.v. morphine in doses based on age and weight.
Patient are being monitored for 6 hours. The primary outcome is reduction in VAS at rest from baseline to 30 minutes after nerve block.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients planned for arthroscopic shoulder surgery.
- •ASA class ≤ 3.
排除标准
- •Patients with VAS never ≥5 mm during the first hour after arrivel to the post anesthesia care unit.
- •Patients unable to cooperate.
- •Patients unable to understand or speak danish.
- •Allergy towards the used drugs.
- •Abuse of alcohol- and/or medicine - investigators assessment.
- •Usage of opioids on a daily basis (not including Tramadole).
- •Pregnancy (It is obligatory for all fertile women in the study to take a hcg urine test).
- •Operations involving the clavicle.
- •Operations converted to open surgery.
研究组 & 干预措施
Ropivacaine hydrochloride
Ropivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve.
干预措施: Ropivacaine hydrochloride (Drug)
Ropivacaine hydrochloride
Ropivacain 7.5mg/ml, 5 ml injected perineural at the suprascapular nerve.
干预措施: PCA-pump (Drug)
Isotonic Saline
0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve.
干预措施: Isotonic Saline (Drug)
Isotonic Saline
0.9% Saline solution, 5 ml injected perineural at the suprascapular nerve.
干预措施: PCA-pump (Drug)
结局指标
主要结局
Visual analogue scale (VAS) score at rest at T½
时间窗: Baseline to 30 minutes
Change in VAS score at rest from baseline to 30 minutes after nerve block (T½).
次要结局
- VAS score during maximum active shoulder abduction from T½ to T6(½, 1, 2, 3, 4, 5, 6 hours)
- Morphine consumption.(6 hours)
- VAS score at rest from T½ to T6(½, 1, 2, 3, 4, 5, 6 hours)
- Muscle strength at T½(Baseline to 30 minutes)
- Electromyography at T½(Baseline to 30 minutes)
研究者
Kai Henrik Wiborg Lange
Head of Research
Hillerod Hospital, Denmark