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临床试验/NCT00289419
NCT00289419已完成4 期

Postoperative Analgesia After Total Hip Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Intraarticular Bolus Injection.

University of Aarhus1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2005年2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
已完成
入组人数
80
试验地点
1
主要终点
Consumption af analgesics

研究概览

简要总结

The purpose of this study is to determine whether wound infiltration with following single-shot bolus injection with local anesthetic and NASIDs are effective in the treatment of postoperative pain after total hip replacement compared to continuous epidural infusion.

详细描述

Sufficient postoperative pain relief after total hip replacement is necessary to achieve normal mobilisation and a reduction of the surgical stress response. After total hip replacement epidural treatment has proven superior, with regards to pain relief, than treatment with parenteral infusions and periphery nerve blocks. Even though epidural treatment gives excellent pain relief adverse effect as motor block, urine retention, hypotension and itching occurs regularly which delays rehabilitation.

Treatment with the administration of local anesthetic in the operating field has shown its efficiency in reducing postoperative pain with a low incidence of adverse effects after various surgical procedures.

This study compares continuous epidural infusion of ropivacaine added morphine to a new technique, where ropivacaine, ketorolac and adrenaline is used to infiltrate the tissue around the hip joint during surgery, and is injected by an intraarticular catheter 8 hours postoperative.

Data of pain scores, analgesia consumption, adverse effects and mobilisation is collected for the first 4 postoperative days.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted consecutively to primary total hip arthroplasty due to arthrosis

排除标准

  • Patients unable to provide informed consent
  • Patients with contraindications for spinal anesthesia
  • Patients with known hypersensitivity towards the used drugs
  • Patients with severe chronic neurogenic pain
  • Patients with Rheumatoid arthritis
  • Patients with a daily opioid consumption

研究组 & 干预措施

A

Active Comparator

干预措施: Epidural Ropivacaine, morphine (Drug)

B

Experimental

干预措施: Ropivacaine, Ketorolac and Adrenaline (Drug)

结局指标

主要结局

Consumption af analgesics

时间窗: 96 h

次要结局

  • Side effects(96 h)
  • Mobilization level(8 h)
  • Pain scores VAS(96 h)

研究者

申办方类型
Other

研究点 (1)

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