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临床试验/CTRI/2026/02/103330
CTRI/2026/02/103330尚未招募不适用

To study the effect of adding single dose morphine to epidural 0.2 percent ropivacaine injection for the management of pain following knee arthroplasty

Dayanand Medical college and Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年2月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
Total rescue analgesia consumption in 24 hours

研究概览

简要总结

Total knee arthroplasty is associated with significant postoperative pain, which can delay rehabilitation and prolong hospital stay if inadequately managed. Epidural analgesia is commonly used after TKA, and addition of opioids such as morphine may enhance analgesic efficacy. This prospective, randomized, double-blind study will be conducted on 62 adult patients, ASA physical status I–III, scheduled for unilateral TKA under combined spinal–epidural anaesthesia . These patients will be enrolled and randomly allocated into two equal groups. All patients will receive continuous epidural infusion of 0.2% ropivacaine for 24 hours postoperatively. After 24 hours, patients in Group A will receive a single epidural dose of morphine 3 mg added to 0.2% ropivacaine ,total volume 6 ml , while Group B will receive normal saline added to 0.2% ropivacaine total volume 6 ml. The epidural catheter will then be removed. Postoperative monitoring will include vital parameters, numeric rating scale (NRS) pain scores, and rescue analgesic consumption for 24 hours following the epidural injection. The primary outcome is total rescue analgesic consumption over 24 hours. The secondary outcome is postoperative pain intensity assessed using the NRS.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I to grade III.

排除标准

  • Any contraindication to neuraxial blockade
  • Allergy or hypersensitivity to morphine or local anesthetics
  • History of chronic opioid use or substance abuse
  • Significant respiratory disease (e.g. severe chronic obstructive pulmonary disease or sleep apnea)
  • Renal insufficiency requiring dialysis
  • Severe hepatic impairment
  • Inability to use the numeric pain rating scale e.g. cognitive impairment or language barrier
  • Patients with high body mass index
  • ASA grade IV and higher.

结局指标

主要结局

Total rescue analgesia consumption in 24 hours

时间窗: Patient will be observed at the time of administration of the study drug , then every hourly till 4 hours and then every hourly till 24 hours

次要结局

  • Post operative pain scores as assessed by NRS(Patient will be observed at the time of administration of the study drug , then every hourly till 4 hours and then every hourly till 24 hours)

研究者

发起方
Dayanand Medical college and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sandeep Kundra

Dayanand Medical College and Hospital

研究点 (1)

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