Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- visual analog scale (VAS) score
研究概览
简要总结
The aim of this study is to compare the possible efficacy of baclofen and gabapentin on postoperative pain in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Age between 18-60 years old.
- •Both male and female patients will be included.
- •Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes.
- •Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity.
- •Patients fit for anesthesia and surgery.
排除标准
- •Patients with BMI >55 kg/m
- •Patients with previous procedures for the treatment of obesity.
- •Pregnant females and lactating women.
- •Patients with psychological or psychiatric disease
- •Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery
- •Patients who experienced vomiting within 24 hours before surgery.
- •Patients with history of alcohol or drug abuse.
- •Patients with hypersensitivity or contraindications to any of the drugs used in this study.
研究组 & 干预措施
Group 1 (baclofen)
which will include 50 patients scheduled for sleeve gastrectomy and will receive 10 mg oral baclofen 1 h before anesthesia.
干预措施: Baclofen 10mg (Drug)
Group 2 (gabapentin)
which include 50 patients scheduled for sleeve gastrectomy and will receive 600 mg oral gabapentin 1 h before anesthesia.
干预措施: Gabapentin (Drug)
结局指标
主要结局
visual analog scale (VAS) score
时间窗: The first 48 hours after surgery.
During the first 48-h postoperative study period, patients were asked to rate their intensity of pain using visual analog scale (VAS) scores. the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
次要结局
- sedation score(The first 48 hours after surgery.)
研究者
Aya Gamal Moussa
Assistant Lecturer at Clinical Pharmacy department , Faculty of Pharmacy -Tanta University
Tanta University