Low Dose Extended-release Epidural Morphine in Conjunction With Lumbar Plexus Block Versus Lumbar Plexus Block Alone for Total Hip Resurfacing Arthroplasty: A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Length of Hospital Stay After Surgery
研究概览
简要总结
At Wake Forest University, the investigators have been using Extended Release Epidural Morphine (EREM), since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties.
Hypothesis:
In patients undergoing a Birmingham total hip arthroplasty (BHA), low dose EREM in conjunction with lumbar plexus block (LPB) will be better than lumbar plexus block alone in increasing proportion of patients who meet discharge criteria within 24 hours.
详细描述
Extended release epidural morphine (EREM, DepoDur®: Endo Pharmaceuticals, Chadds Ford PA) has been studied and increasingly utilized as a method to allow for the improved post-operative analgesia of epidural analgesia without infusions.
At Wake Forest University, the investigators have been using EREM, since late 2004, as part of multimodal analgesia in patients having gynecologic surgeries and hip arthroplasties. The investigators initially decreased our dosages from those recommended (15 mg for lower extremity surgery and 10-15 mg for abdominal surgery), because side effects (nausea, vomiting and hypotension) were felt to be limiting to recovery. The investigators now use 4-7.5 mg in most patients, with 7.5 mg being the exception and have achieved better results. For hip arthroplasties, the investigators currently use 4-5 mg and have performed two retrospective chart reviews on this use; both suggesting that this approach is efficacious. However, these doses have not been studied in a prospective, randomized, double blind trial. The investigators would like to evaluate the efficacy of this dose of EREM used as part of a multimodal regimen. The investigators will compare EREM 4 mg with lumbar plexus block versus lumbar plexus block alone, (providing the rest of our multimodal approach for both patients).
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A primary unilateral Birmingham hip arthroplasty
- •Men and women 18-65 years
排除标准
- •Refusal of regional anesthesia
- •Laboratory evidence of coagulopathy (platelet count less than 100,000 cells/microliter of blood, prothrombin time greater than 12.1 seconds, partial thromboplastin time greater than 30 seconds, or international normalized ratio of greater than 1.5)
- •Allergy to morphine
- •Obstructive sleep apnea
- •Body mass index (BMI) greater than 40 kg/m2
- •Pregnant or lactating
- •Severe renal or hepatic disease
研究组 & 干预措施
Extended Release Epidural Morphine
Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline
干预措施: Extended Release Epidural Morphine (EREM) (Drug)
Placebo Group
The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush
干预措施: Placebo (Drug)
结局指标
主要结局
Length of Hospital Stay After Surgery
时间窗: From surgery day to hospital discharge, up to 4 days
次要结局
- Total Opioid Consumption(96 hours)
- Patient Satisfaction Score(96 hours)
- Distance Walked at Walking Test(96 hours)
- Verbal Pain Scores Post-gait(4 Days Post Surgery)
