Pre- vs. Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Subjective pain intensity, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain)
研究概览
简要总结
Background and Objectives: Neuraxial administration of morphine is an effective way of controlling postoperative pain and reducing analgesic consumption. Several animal models have demonstrated that preemptive administration of neuraxial narcotics reduced pain while others revealed the induction of post-incisional hypersensitivity. There have been no consistent results in clinical setting either. This double blind, randomized study compared the effects of PRE- vs. POST-incisional administration of neuraxial morphine on postoperative pain perception and analgesic requirements over 48 hours following laparotomy for open colectomy under standardized general anesthesia.
Methods: Twenty patients received epidural morphine (3 mg) pre-incision and saline after wound closure (MO1 group), and 20 patients received epidural saline before incision and morphine after wound closure (MO2 group). Postoperatively, all patients received boluses of morphine (1.5 mg) via intravenous patient-controlled analgesia (IV-PCA), and rescue doses of intramuscular diclofenac (75 mg) every 6 hours, as needed.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •1.adults scheduled for elective laparotomy and colon surgery with the duration of surgery expected to last for at least 2 hours.
排除标准
- •allergy to morphine, fentanyl, non-steroidal anti-inflammatory drugs or any of the intraoperative anesthetic medications
- •use of opioids, sedatives or stimulants during 21 days prior to surgery, psychiatric illness
- •congestive heart failure, respiratory failure, neuromuscular disease or presence of a chronic pain syndrome
- •Pregnant women and patients unable to sign their own consent form
研究组 & 干预措施
group 1
NS preoperatively and MO postoperatively
干预措施: normal saline 3 ml, morphine 3mg (Drug)
group 2
MO preoperatively and NS postoperatively
干预措施: normal saline 3 ml, morphine 3mg (Drug)
结局指标
主要结局
Subjective pain intensity, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain)
时间窗: 48 hours
次要结局
- Consumption of analgesics(48 hours)