A Comparison of Postoperative Morphine Consumption in Patients Undergoing Elective Total Abdominal Hysterectomy With Preoperative Analgesia Intravenous Paracetamol Versus Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Compare postoperative morphine consumption between the IV paracetamol and control groups.
研究概览
简要总结
The study aim to study to evaluate whether IV paracetamol reduces morphine use after TAH. Primary objective was to compare postoperative morphine consumption between the IV paracetamol and control groups.
and Secondary objective was to compare postoperative pain scores using the Numeric Rating Scale OR NRS
详细描述
We conducted a randomized, double-blind, placebo-controlled trial at our hospital (QSMH) , including women undergoing elective TAH The trial was conducted between October 2024 (two thousand twenty-four) and May 2025 (two thousand twenty-five) , with approval from the institutional review board.
Participants were randomized 1:1 (one to one) to receive IV paracetamol 1 g or IV normal saline, administered in the operating room before induction of anesthesia, Postoperatively, pain was assessed intermittently using the NRS (์numeric rating scale) at 1, 6, 12, and 24 hours, with morphine 0.1 mg/kg (zero point one milligrams per kilogram) Intravenous provided on demand.
The primary outcome was the number of morphine injections within 24 hours; the secondary outcome was NRS pain scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 30-50 years.
- •Scheduled to undergo total abdominal hysterectomy (TAH) at Queen Savang Vadhana Memorial Hospital at Sriracha
- •No history of allergy to paracetamol (acetaminophen) or morphine.
- •Normal renal function: serum creatinine ≤ 1.2 mg/dL.
- •No severe or recurrent liver disease, and AST or ALT ≤ 3× the upper limit of normal.
- •Able to communicate in Thai, complete the questionnaire, and provide written informed consent (no restriction on race or nationality).
排除标准
- •Incomplete medical record.
- •Use of any analgesic medications within 24 hours preoperatively.
- •Receipt of any postoperative analgesic other than morphine during the first 24 hours after surgery.
- •Withdrawal from the study.
- •Adverse reaction after administration of the study drug.
- •Concomitant surgery involving other organs (e.g., ovary or lymph nodes).
研究组 & 干预措施
Paracetamol
Patients which recieved intravenous paracetamol preoperatively
干预措施: Paracetamol (Drug)
Placebo
Patients which recieved placebo preoperatively
干预措施: Placebo (Drug)
结局指标
主要结局
Compare postoperative morphine consumption between the IV paracetamol and control groups.
时间窗: at 1, 6, 12, and 24 hours postoperation
次要结局
- Compare postoperative pain scores using the Numeric Rating Scale OR NRS(at 1, 6, 12, and 24 hours postoperation)