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临床试验/NCT06872528
NCT06872528尚未招募不适用

Comparison of Epidural Analgesia With Intra-Articular Infiltration Analgesia for Postoperative Total Knee Arthroplasty Analgesia: A Prospective, Randomized Controlled Trial

Namik Kemal University0 个研究点目标入组 30 人开始时间: 2025年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
Amount of local anesthetic used for epidural analgesia

研究概览

简要总结

The results of combining infiltrative analgesia applied by orthopedists with epidural analgesia applied by anesthesiologists after knee replacement surgery will be compared.

It aims to compare epidural analgesia with the maximum reduction of postoperative pain in patients, as well as in terms of both analgesic and complications.

The study will include patients who have undergone knee replacement surgery for six months. In the study, we will compare the results of painkillers applied to the patient from the waist or knee after the waist numbing anesthesia, which includes some of the routinely applied protocols of your knee replacement surgery. It is a condition that will be monitored after surgery. The study aims to reduce maximum pain with two painkiller methods applied in small amounts or together. No interventional application will be made to the patient who will undergo surgery other than routine application. After the surgery, you will be asked verbally about your pain level and side effects at certain hours after the surgery and the amount of painkillers used and the amount of painkillers will be determined according to the follow-up hours (1st, 2nd, 6th, 12th, 24th and 48th hours after the surgery). In addition to these, complications will also be monitored. The results of patients who can be fully followed up at the end of 6 months will be presented as a scientific study.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age range 18-75
  • •Those who underwent surgery with combined spinal anesthesia
  • •Drugs administered with combined spinal anesthesia and intra-articular infiltration analgesia

排除标准

  • •Those who do not want to participate in the study
  • •Those who underwent surgery under general anesthesia
  • •Patients outside the specified age range
  • •Patients with inadequate follow-up results (patient, drug and device related)

研究组 & 干预措施

Analgesia provided with epidural analgesia and local infiltration

Active Comparator

干预措施: Recording the amount of medication and the number of complications according to observational follow-up (Other)

Analgesia provided only with epidural analgesia

Active Comparator

干预措施: Recording the amount of medication and the number of complications according to observational follow-up (Other)

结局指标

主要结局

Amount of local anesthetic used for epidural analgesia

时间窗: 6 months

Is there a statistical difference between the two groups? Monitoring the effect of local infiltration on the amount of epidural analgesic agent

Differences between the two groups in terms of complications and need for additional analgesia

时间窗: 6 months

The effect of epidural analgesia and infiltration analgesia on complications and additional analgesia needs in patients

次要结局

未报告次要终点

研究者

发起方
Namik Kemal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmet Gültekin

Associate Professor

Namik Kemal University

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