NCT06319859已完成3 期
Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries: A Randomized Controlled Clinical Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to first analgesic requirement
研究概览
简要总结
This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years old.
- •Both genders.
- •ASA I and II class.
排除标准
- •Patient refusal.
- •Known local anesthetic (LA) allergy.
- •Skin lesions or infections at the site of needle insertion.
- •Contraindications to spinal anesthesia.
- •Failure of spinal anesthesia.
- •ASA III and VI class.
- •Central or peripheral neuropathies.
- •Severe respiratory or cardiac diseases.
研究组 & 干预措施
Group A
Active Comparator
patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally
干预措施: Morphine (Drug)
Group B
Active Comparator
patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first analgesic requirement
时间窗: 48 hours post-operatively
The time to first analgesic required by the patient will be recorded
次要结局
- The incidence of other adverse effects(14 days post-operatively)
- Nalbuphine consumption(48 hours post-operatively)
- Postoperative pain(at 2, 4,8,12,18,24,30,36,42, and 48 hours post-operatively)
研究者
AbdElKhalik Mahmoud Shaban
Lecturer of anaesthesia
Cairo University
研究点 (1)
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