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临床试验/NCT04403711
NCT04403711已完成不适用

The Effect of Adding Dexmedetomidine to the Local Anesthetic Solution for Ultrasonography-guided TAP Block in Inguinal Hernia Repair

Aretaieion University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月1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
60
试验地点
2
主要终点
pain score 3 hours postoperatively

研究概览

简要总结

This prospective double-blind randomized study will aim at evaluating the short- and long-term postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane (TAP) block with a combination of local anesthetic and dexmedetomidine in inguinal hernia repair under general anesthesia

详细描述

Inguinal hernia repair is one of the most commonly performed surgical procedures worldwide, especially in the day-case setting. It can be accompanied by moderate to severe postoperative pain, which can delay return to normal daily activities or lead to the development of chronic pain. Chronic pain after hernia repair has a reported prevalence ranging between 0% and 43% with both nociceptive and neuropathic features. The transversus abdominis plane (TAP) block is an effective regional anesthetic technique to reduce postoperative pain intensity, time to first rescue anesthetic administration and opioid demand after upper and lower abdominal surgery. Dexmedetomidine is a selective α2-adrenergic agonist with analgesic properties that has been shown to prolong local anesthetic action when used as an adjunct to local anesthetic solutions in neuraxial anesthesia. The aim of this prospective, double-blind placebo controlled randomized study will be to evaluate the analgesic efficacy of ultrasound-guided TAP block where local anesthetic is supplemented by dexmedetomidine in patients undergoing unilateral elective inguinal hernia repair with the Lichtenstein technique under general anesthesia.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) patients I-III undergoing inguinal hernia repair with a mesh
  • open hernia repair
  • elective surgery

排除标准

  • inability to consent to the study due to language barriers or cognitive dysfunction -
  • bilateral inguinal hernia repair,
  • body mass index over 40 kg m-2,
  • skin infection at the puncture site
  • contraindication to paracetamol or non-steroidal anti-inflammatory drug (NSAIDs) administration
  • known previous hepatic or renal impairment as assessed by the patients' history and routine biochemical markers
  • coagulation abnormalities
  • history of gastroesophageal reflux and preoperative use of opioids or NSAIDs for chronic pain conditions
  • reoperation of recurrent inguinal hernia after previous mesh repair

结局指标

主要结局

pain score 3 hours postoperatively

时间窗: 3 hours after surgery

pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

pain score 6 hours postoperatively

时间窗: 6 hours after surgery

pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

pain score 24 hours postoperatively

时间窗: 24 hours after surgery

pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

次要结局

  • incidence of chronic pain(6 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Kassiani Theodoraki

Professor of Anesthesiology

Aretaieion University Hospital

研究点 (2)

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