Effects of Combination of Continuous Intravenous (IV) Infusion Plus Patient-Controlled Analgesia (PCA) of Morphine (MO) vs. IV-PCA MO on Postoperative Pain Control
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- demand/delivery ratio for MO and rescue drug
研究概览
简要总结
After major surgery, such as abdominal or thoracic surgery, the majority of patients experience moderate to severe pain that may not be optimally controlled. Inadequate pain relief may lead to complications that can hinder rehabilitation and slow recovery. Morphine (MO) is the most commonly used opioid for the treatment of post-surgical pain (14). The preferred method of administration nowadays is intravenous patient-controlled analgesia (PCA). In contrast, Continuous infusion of intravenous morphine (CIVM) is seldom used in Post-Anesthesia Care Units (PACUs) for acute postoperative pain, due to concerns of cardio-respiratory deterioration, even though different studies have found this technique of administration effective and safe (in terms of opioid-related symptoms.As part of our efforts to improve postoperative pain management in the Tel Aviv Sourasky Medical Center's PACU, we wish to determine if combining CIVM with IV PCA will be superior over IV PCA only for the treatment of postoperative pain following major abdominal or thoracic surgery.Our hypothesis is that the continuous infusion, even if given at a relatively low dose, would enable the build-up of pharmacologically effective MO blood level, thus providing an overall better control of pain.
详细描述
Study objective To compare the efficacy of two MO administration-protocols: PCA MO (only) vs combination of continuous background infusion plus PCA MO (combined dosage) in patients after abdominal and thoracic surgery.
Methods Inclusion criteria The study will be conducted as a prospective, randomized, double blinded one, into which we will enroll patients aged 18-80 years undergoing major abdominal procedures (e.g. laparotomy, nephrectomy, gastrectomy, gastric bypass, pancreatectomy, splenectomy, and abdominal aortic aneurysm) or thoracic surgery (segmentectomy, lobectomy or pneumonectomy) in our institution during the years 2008-9.
Exclusion criteria We will exclude from the study patients with a history of drug or alcohol abuse, psychiatric disturbances, senile dementia, Alzheimer's disease, seizures or suicide risk, use of psychotropic drugs, pregnancy or nursing, hypersensitivity to MO, or to non steroidal anti-inflammatory drugs (NSAIDs) or their excipients, chronic or acute pain of any origin, respiratory failure or insufficiency, uncompensated or congestive heart or hepatic failure and those scheduled for an emergency or palliative procedure. We will also exclude patients using antidepressants, anticonvulsants or muscle relaxants, and patients using any monoamine oxidase inhibitor within 2 weeks of surgery.
Post enrollment dropouts Patients will be dropped from the study for one of the following reasons: need for immediate postoperative artificial ventilation lasting over 4 h, lack of coherence (<5/10) or constant sedation (>5/10 VAS), or combative behavior in the PACU, postoperative requirement for re-intervention and/or transfer to an intensive care unit (ICU). Other suitable patients will be recruited to replace the ones that were dropped.
Intra-study non-replaced dropouts will include protocol violation, patient's decision to withdraw or ineffective drug protocol (pain >5/10 VAS despite full and evidenced protocol implementation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing major abdominal procedures (e.g. laparotomy, nephrectomy, gastrectomy, gastric bypass, pancreatectomy, splenectomy, and abdominal aortic aneurysm) or thoracic surgery (segmentectomy, lobectomy or pneumonectomy) in our institution during the years 2008-9.
排除标准
- •patients with a history of drug or alcohol abuse, psychiatric disturbances, senile dementia, Alzheimer's disease, seizures or suicide risk, use of psychotropic drugs, pregnancy or nursing, hypersensitivity to MO, or to non steroidal anti-inflammatory drugs (NSAIDs) or their excipients, chronic or acute pain of any origin, respiratory failure or insufficiency, uncompensated or congestive heart or hepatic failure and those scheduled for an emergency or palliative procedure.
- •we will also exclude patients using antidepressants, anticonvulsants or muscle relaxants, and patients using any monoamine oxidase inhibitor within 2 weeks of surgery.
研究组 & 干预措施
1
Patients in this arm will recieve a combination of PCA MO (10 ug/kg/bolus, by request) and continuous infusion of MO (10 ug/kg/h), when visual analog scale (VAS) exeeds 5/10 boluses will be self-administered by the patient.
干预措施: a combination of PCA MO and continuous infusion of MO (Drug)
2
Patients in this arm will be administered with only boluses of 1.5 mg/bolus of MO, by request.
干预措施: PCA MO only (Drug)
结局指标
主要结局
demand/delivery ratio for MO and rescue drug
时间窗: hourly and 12 h total drug consumption
次要结局
- pain intensity(hourly)