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临床试验/NCT03685188
NCT03685188Enrolling By Invitation4 期

Comparison of Oxycodone and Sufentanil for Analgesic Efficacy After Hip Surgery: a Prospective, Multicenter Randomized Controlled Trial

West China Hospital1 个研究点 分布在 1 个国家目标入组 570 人开始时间: 2018年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
Enrolling By Invitation
入组人数
570
试验地点
1
主要终点
Postoperative numerical rating scales (NRS) at rest

研究概览

简要总结

We design this randomized controlled trial to compare the safety and efficacy of Oxycodone and Sufentanil for postoperative patient-controlled analgesia in patients undergoing hip surgery, with a view to finding the optimal postoperative analgesic regime with fewer adverse reactions and promoting patients' rehabilitation.

详细描述

Hip surgery is a common type of orthopedic surgery. The pathologies are complex, including chronic conditions such as femoral head necrosis, primary hip dysplasia, hip joint osteoarthritis and rheumatoid arthritis, as well as acute diseases such as femoral neck fractures and intertrochanteric fractures. The surgical treatment includes closed reduction and internal fixation, open reduction and internal fixation, hemiarthroplasty (femoral head replacement), and total hip arthroplasty, etc. The population of patients undergoing hip surgery has a high proportion of elderly (>65 years old), with multiple preoperative comorbidities, and significant postoperative pain. We must achieve the balance between the providing sufficient analgesia and minimizing associated adverse reactions perioperatively for such group of patients, therefore promoting patients' rehabilitation.

Sufentanil, a pure μ receptor agonist with active metabolite, is a long-acting strong opioid which has high analgesic efficacy. It is commonly used in anesthesia practice, not only for intraoperative analgesia, but also postoperative pain relief, i.e. a popular drug of choice used for Patient Control Intravenous Analgesia (PCIA). However, sufentanil is associated with high incidence of postoperative nausea and vomiting (PONV), respiratory depression and other adverse reactions, which could negatively affect the patient's analgesic satisfaction, and compromise the course of postoperative recovery. It is important to establish an effective and safe postoperative analgesic regime that can achieve the comparable analgesic efficacy with reduced incidence of adverse reactions. Oxycodone is a semi-synthetic opioid which is extracted from the thebaine, it activates both μ and κ opioid receptors. It has been reported to have good analgesic effect and lower incidence of adverse reactions such as PONV in comparison with Morphine, and could be a reasonable option for PCIA. As Oxycodone can agonize κ receptors and reduce visceral pain, most of the existing studies on Oxycodone are focused on laparoscopic cholecystectomy and other abdominal surgeries, with the average age of study patients is between 40 to 55 years old, and also lack of large sample studies.

Based on the abovementioned literatures, we propose the hypothesis that in hip surgery, compared with Sufentanil PCIA, the equipotency dose of Oxycodone PCIA can achieve the same postoperative analgesic efficacy and may also reduce the incidence of adverse reactions associated with opioids.

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 (Participant, Care Provider, 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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Oxycodone group

Experimental

PCIA is formulated at 0.4 mg/ml of oxycodone.

干预措施: Oxycodone Hydrochloride (Drug)

Sufentanil group

Active Comparator

PCIA is formulated at 2 μg/ml of sufentanil.

干预措施: Sufentanil Citrate (Drug)

结局指标

主要结局

Postoperative numerical rating scales (NRS) at rest

时间窗: Up to 72 hours after operation

Resting NRS pain scores at 2 h after surgery.

次要结局

  • Motion of hip joints(Up to 72 hours after operation)
  • Incidence of post operative nausea and vomiting (PONV)(Up to 72 hours after operation)
  • The severity of first PONV and the most severe PONV(Up to 30 days after operation)
  • Time from the end of operation to the first onset of PONV(Up to 30 days after operation)
  • Postoperative numerical rating scales (NRS) at rest(Up to 72 hours after operation)
  • Postoperative NRS on movement(Up to 72 hours after operation)
  • Postoperative complications(Up to 30 days after operation)
  • Straight leg raising time(Up to 72 hours after operation)
  • Ground exercise time(Up to 72 hours after operation)
  • Mobilization time(Up to 72 hours after operation)
  • Residual amount of drug(Up to 72 hours after operation)
  • Postoperative analgesics requirement(Up to 72 hours after operation)
  • Total in-hospital cost.(Up to 30 days after operation)
  • Length of stay (LOS) in hospital(Up to 30 days after operation)
  • Postoperative LOS(Up to 30 days after operation)
  • Re-admission rate(Up to 30 days after operation)

研究者

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

Ren Liao

Associate professor

West China Hospital

研究点 (1)

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