NCT06383234已完成不适用
REduced Pain After Bariatric Surgery - Sleeve Gastrectomy
Fondazione Policlinico Universitario Campus Bio-Medico2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年1月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Pain Score
研究概览
简要总结
This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic sleeve gastrectomy. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective Laparoscopic Sleeve Gastrectomy
- •Body Mass Index (BMI) > 35 kg/m² and at least one condition related to obesity (e.g., hypertension, type II diabetes, dyslipidemia, hepatic steatosis, etc)
- •BMI > 40 kg/m², even in the absence of comorbidities
- •ASA physical status score < 4
排除标准
- •ASA physical status score ≥ 4
- •Patient's refusal or inability to sign the informed consent
- •Allergies to any drug provided by the study protocol
结局指标
主要结局
Pain Score
时间窗: 24 hours
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery
次要结局
- Nausea and/or vomiting(48 hours)
- Time to walking(72 hours)
- Surgical Complication(7 days)
- Time to first flatus(72 hours)
- Morphine Consumption(24 hours)
- Toradol Consumption(24 hours)
- Lenght of Hospital Stay(72 hours)
研究者
Vincenzo Bruni
Principal Invesigator
Fondazione Policlinico Universitario Campus Bio-Medico
研究点 (2)
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