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临床试验/NCT02604797
NCT02604797Unknown不适用

Analgesia Effects of Nalbuphine vs Sulfentanil in Patient-controlled Intravenous Analgesia After Cesarean Section

Fudan University0 个研究点目标入组 80 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
80
主要终点
Pain scores of nalbuphine group

研究概览

简要总结

Cesarean section may result in great trauma and postoperative pain. Besides incision pain, uterine contraction pain is another source of postoperative pain after cesarean section. In clinical practice, a large amount of uterine contraction agent is routinely applied after cesarean section so as to promote involution of uterus and reduce postoperative hemorrhage, which also causes great uterine contraction pain. Acute pain is the risk factor of chronic pain, and may postpone the recovery from labour and influence the quality of life of parturient. Though various analgesia modules have been attempted, more than 20% parturients still experience severe postoperative pain, and pain management after cesarean section remains a challenge to anesthesiologists.

This study aim to compare the effects of nalbuphine hydrochloride vs sufentanil citrate on patient-controlled intravenous analgesia after cesarean section.

详细描述

Cesarean section may result in great trauma and postoperative pain. Besides incision pain, uterine contraction pain is another source of postoperative pain after cesarean section. In clinical practice, a large amount of uterine contraction agent is routinely applied after cesarean section so as to promote involution of uterus and reduce postoperative hemorrhage, which also causes great uterine contraction pain. Acute pain is the risk factor of chronic pain, and may postpone the recovery from labour and influence the quality of life of parturient. Though various analgesia modules have been attempted, more than 20% parturients still experience severe postoperative pain, and pain management after cesarean section remains a challenge to anesthesiologists.

Opiate drugs constitute the baseline medication for postoperative analgesia. However, pure μ opioid receptor agonist like morphine and fentanyl may induce adverse effects such as nausea, vomiting, dizziness, drowsiness and respiratory depression. Nalbuphine hydrochloride is an opiate-like substance structure-related oxymorphone, which is a κ receptor agonist/μ receptor partial antagonistic type analgesia drug. Specific κ receptor agonist and gene knockout experiment reveals that κ receptor agonist depresses the visceral pain induced by chemical stimulation, the effect of which outperforms pure μ opioid receptor agonist. Studies have discovered that some κ receptor agonists can reduce or inhibit the side effects of μ receptor agonist such as tolerance or dependence. The adverse effects of μ receptor agonist such as pruritus, nausea, vomiting, delayed gastric emptying are caused by the drug on peripheral opioid receptor, and can be relieved by opioid receptor agonist. The structure of nalbuphine hydrochloride is related to naloxone, an opioid receptor antagonist, therefore, the incidence of adverse effects of nalbuphine hydrochloride is lower than that of μ receptor agonist. In recent years, nalbuphine hydrochloride has become more and more popular in postoperative analgesia. There has been reports on intrathecal administration of nalbuphine hydrochloride for analgesia after cesarean section, while the effect of intravenous administration of nalbuphine hydrochloride on analgesia after cesarean section remains undetermined. This study aim to compare the effects of nalbuphine hydrochloride vs sufentanil citrate on patient-controlled intravenous analgesia after cesarean section.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • For primipara with selective cesarean section

排除标准

  • Severe preeclampsia,
  • pregnancy complicated with diabetes mellitus
  • pregnancy complicated with cardiac disease,
  • gestation age<37W
  • recently use of opiate drugs or nonsteroidal antiinflammatory drugs within 48 h before operation

研究组 & 干预措施

Nalbuphine

Experimental

Nalbuphine group: nalbuphine 100 mg, ramosetron 0.3mg, background dose 1ml/h,patient-controlled analgesia(PCA) 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation.

干预措施: Nalbuphine (Drug)

Nalbuphine

Experimental

Nalbuphine group: nalbuphine 100 mg, ramosetron 0.3mg, background dose 1ml/h,patient-controlled analgesia(PCA) 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation.

干预措施: flurbiprofen axetil (Drug)

Nalbuphine

Experimental

Nalbuphine group: nalbuphine 100 mg, ramosetron 0.3mg, background dose 1ml/h,patient-controlled analgesia(PCA) 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation.

干预措施: ramosetron (Drug)

Sufentanil

Experimental

Sufentanil group: sufentanil 100ug, ramosetron 0.3mg, background dose 1ml/h, PCA 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation.

干预措施: Sufentanil (Drug)

Sufentanil

Experimental

Sufentanil group: sufentanil 100ug, ramosetron 0.3mg, background dose 1ml/h, PCA 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation.

干预措施: flurbiprofen axetil (Drug)

Sufentanil

Experimental

Sufentanil group: sufentanil 100ug, ramosetron 0.3mg, background dose 1ml/h, PCA 1ml/time, lockout time 10 min, flurbiprofen axetil 50mg 6h after operation.

干预措施: ramosetron (Drug)

结局指标

主要结局

Pain scores of nalbuphine group

时间窗: up to 24 months

Pain scores of sufentanil group

时间窗: up to 24 months

次要结局

  • Usage of nalbuphine of nalbuphine group(up to 24 months)
  • Usage of sufentanil of sufentanil group(up to 24 months)

研究者

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

Sun Shen

Principal Investigator

Fudan University

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