跳至主要内容
临床试验/CTRI/2025/01/079183
CTRI/2025/01/079183尚未招募4 期

A Comparative Study to Evaluate Two Different Doses of Epidural Tramadol for Postoperative Analgesia in Patients Undergoing Upper Abdominal Surgery

Government supply1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月31日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1.To compare duration of analgesia in both groups

研究概览

简要总结

The aim of postoperative analgesia is to provide subjective comfort with minimum side effects, with early ambulation and restoration of function. In upper abdominal surgery, the severity of postoperative pain is higher and it restricts the movement of diaphragm which increases the incidence of respiratory complications, hospital stay, surgical morbidity and mortality in these surgeries. Regional analgesia techniques like epidural analgesia with the introduction of local anaesthetics or opioids or mixture of the two in the epidural space is an established method of effective postoperative analgesia. Tramadol hydrochloride is an atypical centrally acting opioid with mixed opioid and non-opioid activity. Epidural tramadol has the benefit of lack of respiratory depresssant effect along with prolonged postoperative pain relief. The aim of the present study is to find out an optimum dose of tramadol hydrochloride to be used epidurally in upper abdominal surgery patients, based on body weight.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I and II, Patients scheduled for upper abdominal surgeries, Elective surgeries.

排除标准

  • ASA grade III, IV and V Age less than 18 and more than 60 years Patients refusing to give consent Patients who are pregnant or lactating Patients having any bleeding diathesis or are on anticoagulant therapy.

结局指标

主要结局

1.To compare duration of analgesia in both groups

时间窗: 24 hours postoperative

2.To study postoperative pain relief in both groups (by numerical rating scale for pain intensity)

时间窗: 24 hours postoperative

次要结局

  • 1.To compare postoperative complication in both groups.(2.Postoperative hemodynamic parameters in both groups.)

研究者

发起方
Government supply
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Diya Rajan

B J Medical College, Ahmedabad

研究点 (1)

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