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临床试验/NCT03248648
NCT03248648已完成2 期

Efficacy of Intra-articular Neostigmine Versus Ketamine for Postoperative Analgesia in Arthroscopic Knee Surgery

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
100
试验地点
1
主要终点
postoperative analgesic consumption

研究概览

简要总结

To compare the efficacy of intra-articular administration of neostigmine versus ketamine as adjuvant analgesics after knee arthroscopy.

详细描述

Arthroscopic knee surgery is commonly performed as an outpatient procedure and is often associated with postoperative pain. Intraarticular (IA) local anesthetics (LA) are often used for prevention of pain after arthroscopic knee surgery; however, the degree of postoperative pain varies. In an effort to find the ideal regime for sufficient, long-lasting postoperative analgesia, many different drugs, including opioids, nonsteroidal anti-inflammatory drugs, ketamine, clonidine, and neostigmine, have been added to the IA LAs The investigators designed this study to compare the efficacy of intra-articular administration of neostigmine versus ketamine as adjuvant analgesics after knee arthroscopy.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • One hundred patients aged above 18-50 years (ASA I or II) scheduled for elective arthroscopic knee surgery under intrathecal anaesthesia will be enrolled in our study.

排除标准

  • Absolute or relative contraindications for intrathecal anaesthesia,
  • Allergy for the studied drugs.
  • Patients having history of cardiovascular, cerebrovascular, and respiratory diseases,
  • Patients receiving chronic pain treatment or hypertension treated with α methyldopa, clonidine or β adrenergic blockers were excluded from the study.

研究组 & 干预措施

Neostigmine group

Active Comparator

At the end of the surgery patients receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.

干预措施: Neostigmine (Drug)

ketamine group

Active Comparator

At the end of the surgery patients receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.

干预措施: ketamine (Drug)

结局指标

主要结局

postoperative analgesic consumption

时间窗: 36 hours postoperative the total consumption of analgesics in the first 36h postoperative

assessment of each patient on his bed at inpatient ward every 4 hours over a 36-hour period

次要结局

  • Postoperative visual analogue pain scale (VAS)(36 hours postoperative)

研究者

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

Amani Hassan Abdel-Wahab

MD

Assiut University

研究点 (1)

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