Comparison of Short-term Sustained-release Opioid With Immediate-release Opioid for Acute Pain Management Following Open Abdominal Urologic Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to Mobilization
研究概览
简要总结
The advantage of slow-release opioid allows for less fluctuation in drug (pain killer) levels in the blood and an extended period within the effective range for pain relief. The slow-release opioids have been preferred over the short-acting opioids because of the longer duration of action, which lessens the frequency and severity of end-of-dose pain.
Herein, the investigators propose the use of low dose slow-release opioid formulation offers better pain control in the first 48 hours post-operatively in open abdominal urologic surgeries.
详细描述
This will be a randomized, double-blind, controlled trial looking at all adult patients undergoing open abdominal urologic surgeries. After assessing the inclusion/exclusion criteria, the patients will be randomized into one of two groups:
Group 1: Sustained-release (long-acting) opioid on a regular basis for 2 days with immediate-release (short-acting) opioid available on an 'as required' basis
Group 2: Immediate-release (short-acting) opioid on an 'as required' basis only.
All patients will have a general anesthetic at the discretion of the anesthesiologist in the operating room and intravenous opioid will be administered in accordance with the anesthesiologists' discretion.
Pain score and analgesic consumption are the outcome measures.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients undergoing open abdominal urologic surgeries
排除标准
- •Patient refusal
- •history of chronic pain
- •allergy to hydromorphone
- •cannot swallow tablets
研究组 & 干预措施
Sustained-release opioid
3mg of sustained-release hydromorphone three times a day
干预措施: Hydromorphone (Drug)
Short-acting opioid
1-4 mg of short-acting hydromorphone 2-4 times a day as needed
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Time to Mobilization
时间窗: Time to mobilize postoperatively up to 5 days
Ability to walk from bed to chair
次要结局
- Pain score(postoperatively day 1, 2, 3)
- Opioid consumption of hydromorphone(Postoperatively in recovery, 24 hours, 48 hours and 72 hours postoperatively)