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临床试验/NCT01359865
NCT01359865终止不适用

The Influence of Anesthetic Technique on Post-operative Pain Scores and Range of Motion in Primary Total Hip Arthroplasty

Milton S. Hershey Medical Center2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
70
试验地点
2
主要终点
To compare analgesia and orthopedic rehabilitation milestones (range of motion) in patients receiving either spinal anesthesia (local anesthetic plus opioid) or general endotracheal anesthesia with lumbar plexus block.

研究概览

简要总结

To compare analgesia and orthopedic rehabilitation milestones in patients receiving either spinal anesthesia (local anesthetic plus opioid) or general endotracheal anesthesia with lumbar plexus block.

详细描述

To compare analgesia and orthopedic rehabilitation milestones in patients receiving either spinal anesthesia (local anesthetic plus opioid) or general endotracheal anesthesia with lumbar plexus block.

: Total hip arthroplasty (THA) is a common surgery worldwide. Despite the prevalence of this procedure, there is no "gold standard" anesthetic. Several different techniques are utilized. The two most common anesthesia modalities are: 1) spinal anesthesia 2) general anesthesia (with or without a peripheral nerve block). The choice of anesthetic technique is often based on the training and experience of the anesthesia provider, as well as the culture of the institution. Both spinal anesthesia (consisting of local anesthetic and opioid) and general anesthesia (combined with lumbar plexus nerve block) can provide adequate intra-operative anesthesia as well as prolonged post-operative analgesia. The goal of this study is to determine if the choice of one of these two anesthetic techniques influences postoperative pain scores and orthopedic rehabilitation markers in patients undergoing primary THA.

Several studies have compared spinal versus general anesthesia in terms of post-operative pain relief, nausea and vomiting, blood loss, and deep venous thrombosis. Most of these studies did not utilize a lumbar plexus nerve block for postoperative analgesia in the general anesthesia subjects. The investigators are not aware of any randomized, controlled studies examining differences in orthopedic outcomes when THA is performed under spinal anesthesia or general anesthesia with lumbar plexus nerve block. These two anesthetic techniques result in different degrees of intraoperative muscle relaxation which may affect post-operative range of motion. Analgesic differences between the two techniques may also affect range of motion and post-operative ambulation.

The investigators propose to compare post-operative pain scores as a primary outcome in patients receiving either spinal anesthesia (bupivicaine with morphine) or general anesthesia with lumbar plexus block for THA. Orthopedic outcomes, including distance of first ambulation, physical therapy range of motion, and limb length discrepancies will be measured as secondary outcomes. Continuous pulse oximetry and capnograpahy data will be recorded for 24 hours postoperatively on all patients. The incidence of urinary tract infections and post-operative nausea and vomiting between groups will be additional measured outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Elective primary THA
  • Surgery by Dr. Fenwick and Dr. Raab
  • Anesthesia clinic pre-operative appointment
  • ASA I, II, III

排除标准

  • Revision THA
  • Prior THA on opposite side
  • Traumatic hip injury
  • Contraindication to neuraxial or regional anesthesia
  • History of post-operative nausea and vomiting > 2 prior general anesthetics
  • Allergy to local anesthetics, morphine, hydromorphone, dexamethasone, or ondansetron
  • History of substance abuse or chronic narcotic use
  • Severe degenerative joint disease to non-operative joint impairing ambulation
  • Severe back pain or spinal cord stenosis limiting ambulation
  • BMI > 40

结局指标

主要结局

To compare analgesia and orthopedic rehabilitation milestones (range of motion) in patients receiving either spinal anesthesia (local anesthetic plus opioid) or general endotracheal anesthesia with lumbar plexus block.

时间窗: Approx one to three month post-op

On arrival to the adult orthopedic/joint reconstruction ward, a physical therapist will assess the range of motion and document the findings in Powerchart using a pre-existing template. This will be the main primary outcome measure along with ongoing pain scale as part of the orthopedic rehabilitation milestones.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Anson

Assitant professor of Anesthesiology

Milton S. Hershey Medical Center

研究点 (2)

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