The Effect of Intraoperative Tramadol on Postoperative Opioid Requirements After Laparoscopic Sleeve Gastrectomy for Morbid Obese Patients (A Retrospective Multicentric Cohort Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- VAS of pain
研究概览
简要总结
Postoperative pain remains a very UNPLEASENTevent, particularly in morbidly obese patients that may be associated with obstructive sleep apnea. Bariatric surgery patients must get safe and efficient analgesia, which is essential given that up to 45 % of patients report substantial pain in the first two days following surgery. The study's purpose was to compare the efficacy and safety of combined tramadol with pethidine versus pethidine alone and to assess their impact on postoperative pethidine requirements after LSG for morbidly obese patients
详细描述
This multicenter cohort research included patients with morbid obesity who had LSG between January 2021 and December 2022. The patients included in the study were allocated to one of two treatment groups that were not randomized but the patients were categorized according to the time of surgery: Group A received Pethidine alone in the period between January 2021 and December 2021, while Group B got Tramadol with pethidine in the period between January 2022 and December 2022. Doses were based on the patient's actual body weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Group A received Pethidine alone in the period between January 2021 and December 2021, while Group B got Tramadol with pethidine in the period between January 2022 and December 2022. Doses were based on the patient's actual body weight.
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with morbid obesity defined as a BMI of more than 40 or
- •BMI less than 35 with at least one comorbidity and
- •ages ranging from 16 to 65, were patients
排除标准
- •Patients under the age of 16 or over 65,
- •Those with severe GERD, leakage
- •pregnancy, or
- •inflammatory bowel disease,
研究组 & 干预措施
Group A received Pethidine alone in the period between January 2021 and December 2021,
received Pethidine alone in the period between January 2021 and December 2021, while
干预措施: Pethidine (Drug)
Group B got Tramadol with pethidine in the period between January 2022 and December 2022.
Group B got Tramadol with pethidine in the period between January 2022 and December 2022.
干预措施: Tramadol with pethidine (Drug)
结局指标
主要结局
VAS of pain
时间窗: 48 hours postoperative
the severity of pain
opioid requirement
时间窗: one month
the need of pethidine
次要结局
- hospital stay(one month)
研究者
Ayman El Nakeeb
Clinical Professor, Gastroenterology surgical center, mansoura university
Mansoura University