Randomized Controlled Trial Comparing the Impact of Deep Versus Moderate/Superficial NMB on Surgical Conditions and Muscle Trauma During Hip Arthroplasty by Direct Anterior Approach Using Minimally Invasive Surgery.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- surgical exposure
研究概览
简要总结
A clinical deep NMB might relax the anterior muscles of the upper leg better than a moderate/superficial block giving a better exposure for the surgeon with less muscle trauma by traction to expose the hip.
a continuous deep NMB (group A) versus a non deep NMB (group B) having a moderate to superficial block imitating common practice today as control group.
Primary objectives are surgical exposure and Secondary objectives are Muscle damage creatine kinase changes, C-reactive protein (CRP), first time leaving bed postoperative, post operative pain as measured by opioid use postoperative at 24h, with a control of max VAS score during first 24 hour, length of hospital stay (LOS), number of adverse events using the Dindo-Clavien surgical complication score, QoR15 measured at 24h on the ward.
详细描述
In this study, CRP levels are choosen as it is measured standard in every total hip arthroplasty (THA) procedure. CK is a good biomarker for muscle trauma and therefore chosen as second marker.
The study is blinded for the treating surgeon, who will be making the assessment for the surgical conditions. The attending anesthesiologist is not blinded as he has to measure NMB in both groups and give a rocuronium infusion to stay deep in the study group. The anesthesiologist and the nurses following the patient on the post anesthetic care unit (PACU) and the ward are different from the attending anesthesiologist and are blinded. They will not be informed by the attending anesthesiologist on randomization allocation.
Randomization:
Group A deep NMB group:
• 0,6 mg/kg LBW Rocuronium is used to facilitate intubation, and followed by an infusion of 1 mg/kg LBW/h , further adapted to keep post tetanic count (PTC) < 3 without informing the surgeon of the depth (surgeon is blinded)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •• Hip arthroplasty by anterior approach using Minimally Invasive Surgery
排除标准
- •• Revision arthroplasty.
- •Allergy or contra indications to use any of the drugs included in anesthesia.
- •Addiction to or chronic opioid use before surgery.
- •Major cardiovascular, pulmonary, liver or renal insufficiency before surgery requiring possible post-operative intensive care admission.
- •Contra indication for a general anesthesia with intubation and mechanical ventilation.
结局指标
主要结局
surgical exposure
时间窗: from incision till end of surgery stop at day zero
After the surgical procedure the surgeon will be asked to score the surgical conditions on an adapted five point Leiden scale (validated scale): max = 5 and best; min = 1 and worst grade 5: optimal surgical conditions, perfect access to the hip joint and excellent visibility. grade 4: good conditions: adequate surgical conditions to perform the surgery, but not optimal grade 3: just acceptable conditions, surgical procedure is jeopardized, but adequate surgical result is still obtained, eventually after additional intervention grade 2: poor conditions, exposure and handling hindered resulting in suboptimal surgical outcome requiring adaptation of procedure or interventions to improve condition. grade 1: extremely poor conditions, the surgeon is unable to work because of the inability to get access to the hip joint because of inadequate muscle relaxation and request to improve conditions first before continuing.
次要结局
- C-reactive protein (CRP)(24 hours after surgery stop at day 1)
- quality of recovery(2 weeks postoperative stop at day 14)
- leaving bed(within 24 hours postoperative stop at day 1)
- creatinine kinase (CK)(24 hours after surgery stop at day 1)
- postoperative complications(up to two weeks postoperative stop at day 14)
- muscle injury(on photo after procedure stop at day zero)
- Length of stay(measured in days up to one week post surgery stop at day 7)