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临床试验/CTRI/2026/02/103899
CTRI/2026/02/103899尚未招募4 期

Effect of epidural morphine-ropivacaine combination bolus versus continuous infusion on pain and IL-6, IL-10 levels in patients undergoing gastrointestinal oncosurgeries - a prospective randomized clinical trial

AIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
70
试验地点
1

研究概览

简要总结

Adult patients (18–70 years), ASA I–III, scheduled for elective open gastrointestinal cancer surgery will be randomized into two groups of 35 each . Group 1 will receive epidural morphine–ropivacaine as intermittent bolus doses and Group 2 will receive the same combination as continuous epidural infusion. All patients will receive standardized general anaesthesia and multimodal postoperative analgesia.Primary outcomes are Pain scores will be recorded for 48 hours using NRS and  their correlation with inflammatory cytokines(IL -6 and IL -10)levels. Secondary outcomes include rescue analgesia requirement, intraoperative hemodynamics, time to mobilisation, length of hospital stay, and quality of life at 3 months assessed using the FACT-G questionnaire. Study will be Prospective, randomized, open-label, two-arm, parallel-group clinical trial.Duration of study will be 1 yr 6 months .

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 70.00 Year(s)(—)
性别
All

入选标准

  • ASA I-III undergoing GastroIntestinal Cancer Surgeries 2) scheduled for elective open GI oncosurgeries.

排除标准

  • 1.Known allergy to Local Anaesthetic Agents and opioids 2.Patients on chronic opioid therapy 3.Patients with spine deformities, post spinal surgeries 4.Patients undergoing thoracic surgeries or VATS 5.Coagulopathy
  • Infection at the injection site
  • Pregnancy
  • Patient refusal.

研究者

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

Aswin Suresh

AIIMS Rishikesh

研究点 (1)

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