The Efficacy of Intraoperative Parecoxib Combined With Paracetamol for Reducing Opioid Consumption in Patients Undergoing Breast Cancer Surgery Under General Anesthesia: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative morphine consumption
研究概览
简要总结
Patients undergoing breast cancer surgery experience persistent pain after surgery and subsequent development of chronic pain. Parecoxib or paracetamol has been reported to reduce postoperative pain in mastectomy. The investigators aim to assess the effectiveness of the perioperative administration of parecoxib combined with paracetamol to reduce postoperative acute and subacute breast surgical pain.
详细描述
Patients with breast cancer undergoing mastectomy experience moderate postoperative pain which may persist for more than 3 months and may turn into chronic pain. This may interfere with the daily life of the patients. Proper prophylaxis and management to control postoperative pain are essential. Morphine is the most common drug to control postoperative pain. However, there are many serious side effects, e.g., nausea/vomiting, pruritus, ileus, constipation, sedation, and respiratory depression. Multimodal analgesia comprises the use of a combination of drugs to provide the opioid-sparing effect. Parecoxib, a selective cox-2 inhibitor, and intravenous paracetamol are reported to provide good postoperative analgesia. The investigators aim to apply a combination of parecoxib and paracetamol perioperatively to reduce postoperative morphine consumption.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Normal saline is prepared in the same packages as parecoxib and paracetamol.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with breast cancer undergoing elective mastectomy
- •ASA physical status 1-3
排除标准
- •Allergy to parecoxib, paracetamol, or sulfonamide
- •History of opioid use
- •Renal or hepatic disease
研究组 & 干预措施
Group P
Receives the parecoxib 40 mg iv slowly push plus paracetamol 1 gm (100 mL) infusion drip in 30 min after induction.
干预措施: Parecoxib + paracetamol (Drug)
Group C
Receives normal saline in the same process.
干预措施: Normal saline (Drug)
结局指标
主要结局
Postoperative morphine consumption
时间窗: Up to 24 hours postoperatively
Postoperative morphine requirement
次要结局
- Postoperative pain score(Up to 3 months postoperatively)
- Quality of life score(Up to 24 hours postoperatively)
- Postoperative nausea/vomiting score(Up to 24 hours postoperatively)
研究者
Thepakorn Sathitkarnmanee
Associate professor
Khon Kaen University