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临床试验/NCT06218160
NCT06218160已完成不适用

A Randomized Controlled Study of Ropivacaine Combined With Hydromorphone to Block Lumbar Muscle in Elderly Inguinal Hernia Repair.

Second Hospital of Jilin University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2022年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Related indexes of anesthesia effect: time of onset of anesthesia, duration of anesthesia maintenance.

研究概览

简要总结

To compare the clinical and postoperative analgesic effects of hydromorphone combined with ropivacaine and ropivacaine alone in quadrangular muscle block for open inguinal hernia in elderly patients.

详细描述

Elderly patients selected for Lichtenstein hernia repair in our hospital who met the inclusion and exclusion criteria and obtained informed consent were included in this trial, and were randomly divided into experimental group by random number table method: 0.375% ropivacaine combined with hydromorphone block group, and control group: 0.375% ropivacaine block group alone.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60 and above.
  • Admission to hospital for open inguinal hernia surgery is consistent with the -indications of this surgical modality, ASA grades 1 to
  • No recent use of sedatives, opioids, or other analgesics.
  • Good compliance, signed informed consent.
  • Complete clinical data.

排除标准

  • There are serious cardiovascular and cerebrovascular diseases.
  • Abdominal infection.
  • Coagulation dysfunction or receiving anticoagulation therapy.
  • Local anesthesia drug allergy.
  • Can not cooperate with the corresponding operation, suffering from mental illness.
  • Previous surgical history of the corresponding position in the abdomen that may interfere with the surgical process of this study.

研究组 & 干预措施

Hydromorphone combined with ropivacaine

Experimental

The posterior quadrat block was performed by adding 1mg hydromorphone to 0.375% ropivacaine in a total of 30ml.

干预措施: Hydromorphone combined with ropivacaine (Drug)

ropivacaine

Active Comparator

A mixture of 0.375% ropivacaine for a total of 30ml was performed for posterior quadrate block.

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Related indexes of anesthesia effect: time of onset of anesthesia, duration of anesthesia maintenance.

时间窗: From the start of anesthesia until two days after surgery.

The range of the effective time of anesthesia minus the start time of anesthesia and the maintenance time minus the start time of anesthesia are respectively.The unit of time is minutes.

Related indexes of anesthesia effect: pain after surgery, 6, 12, 18,24, 48h after surgery.

时间窗: From the end of surgery until two days after surgery.

Visual analogue scale (VAS) was used to score the postoperative pain at 6,12,18,24,48h.The score ranges from 0 (no pain) to 10 (most severe pain). The change was equal to the score difference between the two groups at different observation time points (6,12,18,24,48h).

次要结局

  • The occurrence of postoperative adverse reactions.(The operation ended two days after surgery.)

研究者

发起方
Second Hospital of Jilin University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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