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临床试验/NCT03225690
NCT03225690Unknown4 期

Does Preemptive Epidural Morphine Prevent Remifentanil Induced Hyperalgesia

Cukurova University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2017年7月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
105
试验地点
1
主要终点
Postoperative analgesic requirement

研究概览

简要总结

American Society of Anaesthesiologist physical status (ASA) I-III 105 patients who undergoing major abdominal surgery in obstetric and gynaecology clinic were recruited to this study. Patients were randomized into the 3 groups. Lumbar epidural catheter will be inserted to the all patients. After than anaesthesia induction will provide with 2 mg/kg propofol and 0.6 mg/kg rocuronium. Desflurane and azot protoxit (N2O)-O2 will use for anaesthesia maintenance. During surgical operation, 0.3 microgram/kg/h remifentanil infusion will continuous till the end of surgery. In group I, 2 ml serum physiologic (0.9 NaCL)will apply from epidural catheter before surgical incision. In group II, 1 mg morphine will apply from epidural catheter before surgical incision. In group III, 1 mg morphine will apply from epidural catheter at the time point of peritoneum is closed. Epidural patient controlled analgesia will provide with bupivacaine for postoperative analgesia. Postoperative pain will be assessed with numerical pain scale. Postoperative analgesic requirement will be calculated. Hyperalgesia will detect with algometer and von Frey ligaments.

详细描述

This randomized, double blind, controlled study will perform after obtaining informed consent and ethics approval. American Society of Anaesthesiologist physical status (ASA) I-III 105 patients who undergoing major abdominal surgery in obstetric and gynaecology clinic were recruited to this study. Patients were randomized into the 3 groups with computerized randomization programme. Lumbar epidural catheter will be inserted to the all patients. After than anaesthesia induction will provide with 2 mg/kg propofol and 0.6 mg/kg rocuronium. Desflurane and N2O-O2 will use for anaesthesia maintenance. During surgical operation, 0.3 microgram/kg/h remifentanil infusion will continuous till the end of surgery. In group I, 2 ml serum physiologic (0.9 NaCL)will apply from epidural catheter before surgical incision. In group II, 1 mg morphine will apply from epidural catheter before surgical incision. In group III, 1 mg morphine will apply from epidural catheter at the time point of peritoneum is closed. Epidural patient controlled analgesia will provide with bupivacaine for postoperative analgesia. Postoperative pain will be assessed with numerical pain scale. Postoperative analgesic requirement will be calculated. Hyperalgesia will detect with algometer and von Frey ligaments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA I-III patients
  • Patients who undergoing major abdominal surgery

排除标准

  • ASA IV and up
  • Coagulopathy

研究组 & 干预措施

serum physiologic

Placebo Comparator

2 ml serum physiologic will apply via epidural catheter before surgical incision.

干预措施: Serum physiologic (Drug)

Preemptive Morphine

Active Comparator

1 mg morphine will apply via epidural catheter before surgical incision.

干预措施: Morphine (Drug)

Morphine

Active Comparator

1 mg morphine will apply via epidural catheter before at the time point of the peritoneum closed.

干预措施: Morphine (Drug)

结局指标

主要结局

Postoperative analgesic requirement

时间窗: Till the postoperative 24th hour.

Calculation of epidural bupivacain consumption

次要结局

  • Algometer values(Till the postoperative 24th hour.)

研究者

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

ebru biricik

Dr

Cukurova University

研究点 (1)

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