Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 and 0.2 Milligrams in Cesarean Section: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Incidence of pruritus requiring treatment [Time Frame: 24 hours post-operatively]
研究概览
简要总结
This study compares the incidence of pruritus (itching) requiring treatment between two doses of intrathecal morphine (0.1 mg vs 0.2 mg) when used for spinal anesthesia during cesarean section. The study aims to determine if the lower dose (0.1 mg) can reduce pruritus incidence while maintaining adequate pain relief.
详细描述
Spinal anesthesia is a standard technique for cesarean section. Intrathecal morphine (ITM) provides prolonged and effective analgesia but may cause adverse events including pruritus, nausea, vomiting, and respiratory depression. Current practice at Srinagarind Hospital uses ITM 0.2 mg for spinal anesthesia in cesarean section. This study investigates whether reducing the ITM dose to 0.1 mg can decrease pruritus incidence while preserving analgesic effectiveness.
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)
盲法说明
They are unaware of type of drug administered.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women aged 18-45 years
- •Full-term pregnancy
- •Scheduled for non-emergency cesarean section
- •ASA physical status I-III
- •Non-complicated pregnancy
排除标准
- •Contraindication to spinal anesthesia or study drugs
- •Refusal to participate in the study
- •BMI ≥ 40 kg/m²
- •History of systemic skin disease or current itchy skin condition
- •Use of antihistamines or anti-pruritic medications within 3 days prior to surgery
研究组 & 干预措施
ITM 0.1 mg
Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.1 mg intrathecally
干预措施: Morphine Sulfate (Drug)
ITM 0.2 mg
Participants receive spinal anesthesia with 0.5% hyperbaric bupivacaine plus morphine 0.2 mg intrathecally
干预措施: Morphine Sulfate (Drug)
结局指标
主要结局
Incidence of pruritus requiring treatment [Time Frame: 24 hours post-operatively]
时间窗: 24 hours
* Percentage of participants requiring treatment for pruritus within 24 hours after spinal anesthesia * Measured using numerical rating scale (0-10), with treatment indicated for score ≥4 * Percentage of participants requiring treatment for pruritus within 24 hours after spinal anesthesia * Measured using numerical rating scale (0-10), with treatment indicated for score ≥4 * Percentage of participants requiring treatment for pruritus within 24 hours after spinal anesthesia * Measured using numerical rating scale (0-10), with treatment indicated for score ≥4
次要结局
未报告次要终点
研究者
Thepakorn Sathitkarnmanee
Associate professor
Khon Kaen University