Laparoscopic Assisted Transversus Abdominis Plane (TAP) Block Vs Local Anesthetic Infiltrations in Bariatric Surgery: a Prospective Randomized Double-Blind Controlled Trial (TAP BLOCK BARIATRIC TRIAL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
The purpose of this study is to compare the postoperative pain and other clinical outcomes in patients who, during bariatric surgery, will be injected with a local anesthetic (Ropivacaine) through two different techniques.
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
- Double (Participant, Outcomes Assessor)
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
- •patients undergoing elective bariatric surgery
- •age ≥ 18 years
- •signed informed consent
排除标准
- •Pregnant or lactating women,
- •known allergy to local anesthetics
- •Chronic pain syndrome.
研究组 & 干预措施
Arm A - laparoscopic assisted TAP block
Patients will undergo the planned bariatric intervention according to the standard of treatment. A solution of 20 ml of the local anesthetic Ropivacaine (0.25%) is then injected for postoperative pain control according to the allocated procedure (TPA).
干预措施: Transversus Abdominis Plane (TAP) block (Procedure)
Arm B - PSI
Patients will undergo the planned bariatric intervention according to the standard of treatment. A solution of 20 ml of the local anesthetic Ropivacaine (0.25%) is then injected for postoperative pain control according to the allocated procedure (PSI).
干预措施: Port-Site Infiltration (PSI) (Procedure)
结局指标
主要结局
Postoperative Pain
时间窗: at 24 hours post surgery
Postoperative pain on the visual analogue scale (VAS) This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.
次要结局
- in hospital satisfaction(during hospitalization,approximately 4 days)
- postoperative pain(at 3, 6, 12, 18 hours from surgery)
- Number of participants with complications(from surgery up to six weeks after surgery)
- lenght of hospital stay(during hospitalization,approximately 4 days)
- Number of Participants With Ropivacaine-Related Adverse Events(from surgery up to six weeks after surgery)
研究者
Fabio Garofalo
Principal Investigator
Ente Ospedaliero Cantonale, Bellinzona