跳至主要内容
临床试验/NCT03775018
NCT03775018Unknown3 期

Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)

Hospital General Universitario Elche0 个研究点目标入组 140 人开始时间: 2018年12月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
140
主要终点
Postoperative pain

研究概览

简要总结

Patients will be randomized into 2 groups:

  • TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia
  • IV: Patients receiving only intravenous Acetaminophen analgesia

Postoperative pain 24 hours after surgery will be evaluated.

详细描述

Patients will be randomized into 2 groups:

  • TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen analgesia (1g/6h)
  • IV: Patients receiving only intravenous Acetaminophen analgesia (1g/6h)

Postoperative pain 24 hours after surgery will be evaluated, by a Visual Analogic Scale (VAS), ranging from 0 to 100mm.

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)

盲法说明

The analgesic treatment applied will be blinded to the treatment and to the epidemiology nurse who will assess the postoperative pain

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing One-anastomosis gastric bypass (OAGB) as primary bariatric procedure

排除标准

  • Patients undergoing OAGB as revisional procedure
  • Patients undergoing other bariatric procedures
  • Patients undergoing additional surgical procedures during the same surgical act (band removal, cholecystectomy, hernioplasty, or hiatal hernia treatment)
  • Patients with history of allegy to local anesthetic drugs

研究组 & 干预措施

Transversus abdominis plain blockade

Experimental

The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia

干预措施: Transversus abdominis plane blockade (Procedure)

Transversus abdominis plain blockade

Experimental

The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia

干预措施: Intravenous analgesia (Drug)

Intravenous analgesia

Active Comparator

The patients will receive intravenous analgesia with Acetaminophen (1g/6h)

干预措施: Intravenous analgesia (Drug)

结局指标

主要结局

Postoperative pain

时间窗: 24 hours after surgery

Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm

次要结局

未报告次要终点

研究者

发起方
Hospital General Universitario Elche
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaime Ruiz-Tovar, MD, PhD

Department of Surgery

Hospital General Universitario Elche

相似试验