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临床试验/CTRI/2026/01/101256
CTRI/2026/01/101256尚未招募4 期

Comparison on the effects of epidural levobupivacaine and morphine for post operative analgesia following total abdominal hysterectomy

Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月1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

研究概览

简要总结

Total abdominal hysterectomy is associated with significant postoperative pain which may delay recovery and mobilization if not adequately managed. Epidural analgesia is an effective technique for postoperative pain relief in major abdominal surgeries.

This prospective randomized double blind parallel group study aims to compare the efficacy and safety of epidural levobupivacaine and epidural morphine for postoperative analgesia in patients undergoing elective total abdominal hysterectomy. Sixty ASA physical status I and II female patients aged 18 to 65 years will be randomly allocated into two groups. Group L will receive epidural levobupivacaine 0.25 percent 10 mL and Group M will receive preservative free epidural morphine 3 mg diluted to 10 mL with normal saline administered via epidural catheter at the end of surgery.

The primary outcome will be the duration of effective postoperative analgesia defined as time to first request for rescue analgesia. Secondary outcomes include postoperative pain scores using visual analogue scale at predefined time intervals, requirement of rescue analgesia, incidence of adverse effects such as nausea vomiting pruritus respiratory depression hypotension and urinary retention and patient satisfaction scores.

The study aims to determine the optimal epidural analgesic regimen that provides effective pain relief with minimal side effects following total abdominal hysterectomy.

研究设计

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

入排标准

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

入选标准

  • Scheduled for elective total abdominal hysterectomy.
  • ASA I or II.
  • Consent to participate in the study.

排除标准

  • Known allergy to local anaesthetics or opioids.
  • Coagulopathy or local infection at the epidural site.
  • Chronic opioid neurological disorders use or pre-existing neurological disorder.

研究者

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

DR Mohammed Yunus Khilji

Sardar Patel Medical College

研究点 (1)

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