Respiratory Impact of Local Anaesthetic Volume for an Interscalene Brachial Plexus Block With an Extrafascial Approach.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of hemidiaphragmatic paralysis
研究概览
简要总结
The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.
详细描述
The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.
Our prospective randomized controlled trial will include two parallel groups: a group will receive a volume of 20 mls of ropivacaine 0.75%, while the other group will receive a volume of 10 mls.
All participants will have a preoperative ultrasound-guided interscalene brachial plexus with an extrafascial injection of 10 or 20 mls of ropivacaine 0.75%. In both groups, participants will have an examination of the hemidiaphgragm with the ultrasound, before and 30 min after the block. The respiratory function will also be assessed with a bedside spirometer before and after the block, and at 12 and 24 postoperative hours. During surgery all participants will receive multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 milligram kg^2, iv ketorolac 30 milligrams, and iv acetaminophen 1000 milligrams, according to the current practice in our institution. In the postoperative period, Participants will be prescribed an IV pca of morphine.
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
- Triple (Participant, 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
- •arthroscopic surgery of the shoulder
- •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
- •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 (Glomerular Filtration Rate < 20 ml/min)
- •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
10 ml single-shot injection
In the 10ml group, participants will have an interscalene brachial plexus with an extrafascial injection of 10 ml ropivacaine 0.75% at the level of C5-C6 nerves roots.
Participants will also receive multimodal analgesia with injection of dexamethasone 8 mg iv, magnesium sulfate 40 mg kg^-1 iv, ketorolac 30 mg iv, and acetaminophen 1000 mg iv, according to the current practice in our institution.
干预措施: Ropivacaine 0.75% Injectable Solution (Drug)
20 ml single-shot injection group
In the 20ml group, participants will have an interscalene brachial plexus with an extrafascial injection of 20 ml ropivacaine 0.75% at the level of C5-C6 nerves roots.
Participants will also receive multimodal analgesia with injection of dexamethasone 8 mg iv, magnesium sulfate 40 mg kg^-1 iv, ketorolac 30 mg iv, and acetaminophen 1000 mg iv, according to the current practice in our institution.
干预措施: Ropivacaine 0.75% Injectable Solution (Drug)
结局指标
主要结局
Incidence of hemidiaphragmatic paralysis
时间窗: 30 minutes after the interscalene plexus brachial extrafascial injection
次要结局
- Presence of Dyspnea(in phase 1 recovery and at 12 and 24 postoperative)
- Installation time of sensory block(up to 30 minutes after the interscalene plexus brachial extrafascial injection)
- Installation time of motor block(up to 30 minutes after the interscalene plexus brachial extrafascial injection)
- Cumulative postoperative iv morphine consumption(in phase 1 recovery and at 12 and 24 postoperative hours)
- Duration of motor block(up to 24 hours postsurgery)
- Duration of sensory block(up to 24 hours postsurgery)
- Incidence of hemidiaphragmatic paralysis(at 2 and 24 postoperative hours)
- Presence of PONV(in phase 1 recovery and at 12 and 24 postoperative)
- Presence of Pruritus(in phase 1 recovery and at 12 and 24 postoperative hours)
- Presence of Claude-Bernard-Horner syndrome(in phase 1 recovery and at 12 and 24 postoperative hours)
- Presence of Dysphonia(in phase 1 recovery and at 12 and 24 postoperative hours)
- Forced expiratory volume in one second(30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours)
- Forced vital capacity(30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours)
- Peak expiratory flow(30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours)
- Time to first dose of postoperative iv morphine(up to 24 hours postsurgery)
- Pain scores at rest(in phase 1 recovery and at 12 and 24 postoperative hours)
- Pain scores on movement(in phase 1 recovery and at 12 and 24 postoperative hours)
- Duration of analgesic block(up to 24 hours postsurgery)
- Satisfaction of the participants(at 24 postoperative hours)
研究者
Eric Albrecht
Sponsor-Investigator
Centre Hospitalier Universitaire Vaudois