" Analgesic Efficacy of Continuous Infusion of Local Anaesthetic Versus Single-shot Injection Interscalene Brachial Plexus Block in Patients Receiving a Large Multimodal Analgesia: a Randomized Controlled Trial "
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- total i.v. morphine consumption
研究概览
简要总结
The aim of this study is to study the analgesic efficacy of a continuous infusion of local anaesthetics for interscalene brachial plexus block after major shoulder surgery in the setting of multimodal analgesia, in order to determine whether the use of a catheter is still necessary in a contemporary practice.
详细描述
The hypothesis of this study is that in contemporary practice, comprising the administration of multimodal analgesia, the continuous infusion of local anesthetic via a catheter remains superior in terms of analgesia at 24 h compared to a single-shot injection at the level of the interscalene brachial plexus after major shoulder surgery.
This prospective randomized monocentric superiority study will include two parallel groups: a SS (single-shot injection) group and a CI (continuous infusion) group.
All patients will have a preoperative ultrasound-guided interscalene brachial plexus block with 20 ml of lidocaïne 1% and epinephrine 1:100,000, followed by the insertion of a catheter. In the post-operative period, after clinical assessment of motor recovery in the operated limb (flexion of the forearm possible) in order to exclude any neurological damage of surgical origin, ropivacaine 0.5% 20 ml will be injected through the catheter. In the SS group, the catheter will be removed. In the CI group, a continuous infusion of ropivacaine 0.2% at a flow rate of 6 ml.h-1 will be running for 48h after the bolus administration of ropivacaine 0.5%.
In both groups, patients will receive during surgery multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg, according to the current practice in our institution.
Assignment to one of these two groups will be done according to a computer-generated list of random numbers, and the sealed envelopes method will be used.
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
- 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
- •patient scheduled for a major shoulder surgery (total shoulder arthroplasty or rotator cuff repair);
- •ASA class 1 to 3;
- •age more than 18 years old.
排除标准
- •patient refusal or inability to understand and/or sign the inform consent
- •contraindication for perineural block (allergy to local anesthetics, infection of puncture site, major coagulopathy, sensitive or motor deficiency on the operative side arm);
- •chronic alcool abuse;
- •chronic pain under chronic opioid treatment
- •opioid drug abuse or under substitution treatment
- •patients known for allergies to paracetamol, non steroidal anti inflammatory drugs, dexamethasone, sulfate magnesium, ondansetron, droperidol, and omeprazole;
- •patients under chronic corticotherapy
- •patients known for malignant hyperthermia;
- •patients with chronic kidney failure class 3 or more;
- •patients with severe pulmonary disease;
- •patients with history of neck surgery or radiotherapy on the operative side;
- •pregnancy.
研究组 & 干预措施
CI group
Patients will have a preoperative ultrasound-guided interscalene brachial plexus block with 20 ml of lidocaïne 1% and epinephrine 1:100,000, followed by the insertion of a catheter. In the post-operative period, after clinical assessment of motor recovery in the operated limb (flexion of the forearm possible) in order to exclude any neurological damage of surgical origin, ropivacaine 0.5% 20 ml will be injected through the catheter.
Then a continuous infusion of ropivacaine 0.2% at a flow rate of 6 ml.h-1 will be running for 48h after the bolus administration.
During surgery, patients will also receive multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg, according to the current practice in our institution.
干预措施: ropivacaine 0.2% (Drug)
结局指标
主要结局
total i.v. morphine consumption
时间窗: 24 hours postoperatively
i.v morphine consumption in milligrams
次要结局
- overall patient satisfaction rate(at 24 hours and 48 hours postoperatively)
- length of hospital stay(From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months)
- pain score(at 3 months postoperatively)
- presence of PONV(in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively)
- joint amplitude during anterior elevation of the shoulder(at 24 hours and 48 hours postoperatively)
- joint amplitude during shoulder abduction(at 24 hours and 48 hours postoperatively)
- total i.v. morphine consumption postoperative(in the postoperative care unit, at 12 hours, 36 hours, and 48 hours postoperatively)
- pain scores at rest and on movement(in the postoperative care unit, and twice a day during the first 48 hours postoperatively)
- presence of pruritus(in the postoperative care unit and twice a day at 24 hours and 48 hours postoperatively)
- rate of complications related to the catheter(From operative day to hospital discharge or death during hospitalisation whichever came first, assessed up to 3 months)
- joint amplitude during external rotation of the shoulder(at 24 hours and 48 hours postoperatively)
研究者
Eric Albrecht
Principal Investigator PD Dr Eric Albrecht
Centre Hospitalier Universitaire Vaudois