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临床试验/NCT03530280
NCT03530280已完成不适用

Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction (ACL)

Ankara Diskapi Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年6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
51
试验地点
1
主要终点
tramadol consumption

研究概览

简要总结

arthroscopically Anterior Cruciate Ligament Reconstruction (ACL) under spinal anesthesia were included in this study.

详细描述

Patients who American Society of Anesthesiologists (ASA) classification I to II scheduled to undergo arthroscopically assisted ACL reconstructions under spinal anesthesia are included in this study. The first group is administered 150 mg oral pregabalin 1 hour before surgery and the postoperative sham block was performed with an ultrasound probe. The second group is the control group; patients in this group are administered a placebo capsule 1 hour before surgery and sham block was performed with an ultrasound probe.The third group is administered a placebo capsule 1 hour before surgery and postoperative adductor canal block is performed. All patients will be received postoperative a tramadol i.v. patient control analgesia device. At the end of 24 hours, the total amount of tramadol consumed by the patient will be recorded from the patient control analgesia. NRS score, white fast track, satisfaction will be questioned.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 18 and 70 years
  • American Society of Anesthesiologists I or II
  • Scheduled to undergo knee arthroscopy

排除标准

  • allergic to any medicines
  • History of drug or alcohol abuse,
  • Opioids or sedative medications
  • History of psychiatric conditions
  • Pregnant or lactating women

研究组 & 干预措施

pregabalin (lyrica)

Active Comparator

pregabalin (lyrica) 150 mg preoperative 1 hour before and the postoperative sham block will perform.

干预措施: pregabalin (lyrica) (Drug)

placebo group

Placebo Comparator

a placebo capsule 1 hour before surgery and the postoperative sham block will perform.

干预措施: Placebo oral tablet (Drug)

adductor channel block group

Active Comparator

A preoperative placebo capsule will be given.This group will receive postoperative adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine

干预措施: adductor canal block including bupivacaine (Drug)

结局指标

主要结局

tramadol consumption

时间窗: 24 hours

24 hours tramadol consumption will be recorded as milligrams

11-point numerical rating scale (NRS)

时间窗: 24 hours

11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.

次要结局

未报告次要终点

研究者

发起方
Ankara Diskapi Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Kavak Akelma

specialist doctor

Ankara Diskapi Training and Research Hospital

研究点 (1)

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