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临床试验/NCT00934661
NCT00934661终止4 期

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.

Wake Forest University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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