Comparison of Intravenous Patient-Controlled Analgesia With Different Background Infusion After Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Dezocine consumption by patient-controlled analgesia
研究概览
简要总结
In this study, the investigators investigated the efficacy, usefulness and analgesic consumption of three different patient-controlled analgesia(PCA) programmes:bolus dose alone without background infusion, bolus dose with low background infusion and bolus dose with high background infusion to evaluate postoperative analgesia for patients after laparoscopic colorectal surgery.
详细描述
There have been many studies using patient-controlled analgesia (PCA) and opioids for postoperative analgesia.Patient-controlled analgesia with opioids is now widely used after surgery for the treatment of acute postoperative pain. This technique provides effective pain treatment, adjusts the dose according to personal need and keeps plasma analgesic levels at a constant level,but the incidence of opioid-induced side-effects still be reported frequently.A proper PCA programme may increase efficiency of analgesic and decrease incidence of analgesic-induced side-effects.
In this study, 90 patients who is undergoing elective laparoscopic colorectal surgery will be randomly allocated into three groups (no background infusion group(Group B0),low background infusion group(Group B1) and high background infusion group(Group B2)). Patients in all groups will be given a patient-controlled analgesia (PCA) pump in post anesthetic recovery unit (PACU) after surgery.The PCA programme of Group B0 is dezocine 0.6mg/kg, flubiprofen 3mg/kg, diluted into 120ml and administer at a background infusion of 0ml/h, and a bolus of 4ml, with a lock-out of 15min. The PCA protocol of Group B1 is dezocine 0.6mg/kg,flubiprofen 3mg/k diluted into 120ml and administer at a background infusion of 1ml/h, and a bolus of 2ml, with a lock-out of 15min.The PCA protocol of Group B2 is dezocine 0.6mg/kg,flubiprofen 3mg/k diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •American Society of Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing laparoscopic colorectal surgery
- •Written informed consent from the patient or the relatives of the participating patient.
- •BMI:18～30kg/m2
排除标准
- •Mental illness or cannot communicate.;
- •A second operation during the study;
- •Lung infection or sleep apnea syndrome;
- •Renal failure;
- •Alcohol or drug abuse;
- •Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;
- •Long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history .
研究组 & 干预措施
No Background Infusion Group(Group B0)
Patients in Group B0 receive analgesic regimens using Patient-Controlled Analgesia(PCA) with background infusion 0ml/h.
干预措施: Patient-Controlled Analgesia(PCA) (Device)
Low Background Infusion Group(Group B1)
Patients in Group B1 receive analgesic regimens using Patient-Controlled Analgesia(PCA) with background infusion 1ml/h.
干预措施: Patient-Controlled Analgesia(PCA) (Device)
High Background Infusion Group(Group B2)
Patients in Group B2 receive analgesic regimens using Patient-Controlled Analgesia(PCA) with background infusion 2ml/h.
干预措施: Patient-Controlled Analgesia(PCA) (Device)
结局指标
主要结局
Dezocine consumption by patient-controlled analgesia
时间窗: At 24 hours after surgery
The total consumption of dezocine during 24 hours after surgery are recorded.
次要结局
- The incidence rates of postoperative nausea and vomiting (PONV)(At 24 hours and 48 hours after surgery)
- Change in ramsay sedation score(At 0, 2, 4, 8, 24, 48 and 72 hours after surgery)
- Change in pain score(At 0, 2, 4, 8, 24, 48 and 72 hours after surgery)
研究者
Weifeng Tu
Chief physician
Guangzhou General Hospital of Guangzhou Military Command