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临床试验/CTRI/2018/05/013594
CTRI/2018/05/013594招募中4 期

POSTOPERATIVE ANALGESIA WITH EPIDURAL INFUSION OF BUPRENORPHINE VERSUS TRANSDERMAL BUPRENORPHINE IN TOTAL ABDOMINAL HYSTERECTOMY: A COMPARATIVE STUDY

Anju Krishnan1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2017年6月16日

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
174
试验地点
1
主要终点
Postoperative analgesia will be assessed using numerical rating scale.

研究概览

简要总结

Buprenorphine is a potent analgesic widely used for postoperative analgesia especially through the epidural route. Transdermal patches of buprenorphine provide an easy, safe and sustained method of  drug delivery and avoids multiple pricks. This study tries to evaluate efficacy of transdermal buprenorphine in providing postoperative analgesia compared to epidural buprenorphine infusion. Side effects like headache, nausea, vomiting , respiratory depression , pruritis and dizziness will also be watched for.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • a)Age between20 and 65 years.
  • American Society of Anaesthesiologists ASA I OR II.
  • Expected hospital stay after intervention atleast for 72 hrs.
  • Weight 45kg -65kg.

排除标准

  • Any chronic pain syndromes.
  • Chronic obstructive pulmonary disease.
  • Any history of hypersensitivity to opioids or patch additives.
  • Obstructive sleep apnoea.
  • Psychiatric disorders which impact on appropriate data collection.
  • Surgeries lasting for more than 2 hours.

结局指标

主要结局

Postoperative analgesia will be assessed using numerical rating scale.

时间窗: 2hr, 4hr, 12hr, 24hr,36hr, 48hr, 60hr, 72hr after surgery

次要结局

  • side effects like nausea, vomiting, pruritus, headache, diziness(2hr, 4hr, 12hr, 24hr,36hr, 48hr, 60hr, 72hr after surgery)

研究者

发起方
Anju Krishnan
申办方类型
Government medical college

研究点 (1)

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