Role of Wound Installation With Bupivacaine Through Surgical Drains in Postoperative Analgesia in Modified Radical Mastectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Visual analogue pain score
研究概览
简要总结
in this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period
详细描述
patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.
in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) patients and health care providers were blinded as regard the study group patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the patient is annoyed from the pain- was assessed two and four hours post-operative then every four hours thereafter.
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 (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection
排除标准
- •Male patients
- •Bilateral breast cancer.
- •Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse
- •Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection.
- •Patients with known psychological or mental problems.
- •Patients who were not exposed to axillary dissection
研究组 & 干预措施
Bupivacaine
The wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.
干预措施: 40ml of 0.25% bupivacaine (Drug)
Placebo
The wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group)
干预措施: 40ml of 0.9% normal saline (Drug)
结局指标
主要结局
Visual analogue pain score
时间窗: first 24 hours
The intensity of pain will be assessed by the VAS score
Number of demands for analgesic
时间窗: First 24 hours
How many times the patient will require analgesics
Timing of first demand for analgesic
时间窗: First 24 hours
Time lapse between recovery from surgery and first demand for analgesic
次要结局
未报告次要终点
研究者
Mahmoud A. Alhussini
lecturer surgical oncology
Alexandria University