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临床试验/NCT02601651
NCT02601651已完成4 期

Effect of Perioperative Intravenous Lidocaine on Opioid Consumption and Pain After Laparoscopic Totally Extraperitoneal Inguinal Hernioplasty

B.P. Koirala Institute of Health Sciences1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
64
试验地点
1
主要终点
Total morphine requirement during the first 24 h postoperatively

研究概览

简要总结

The primary objectives of this study is to access the effect of perioperative lidocaine infusion on total morphine requirement during the first 24 h postoperatively in patients who underwent laparoscopic totally extraperitoneal inguinal hernioplasty.

详细描述

The use of intravenous lidocaine can be considered as a multimodal approach to pain relief. This method of analgesia has been associated with reductions in post-operative pain, analgesic consumption, nausea, vomiting and length of hospital stay in various surgeries (abdominal, spinal, thoracic surgery) including laparoscopic procedure .The primary reason for delayed patient recovery and longer hospital stays after surgery is postoperative pain and ileus .Opioids are the mainstay drug to treat pain in the postoperative period. However, nausea, vomiting, postoperative ileus and further delay in patient recovery will be exacerbated by opioid administration.

the higher inflammatory response is observed in the early postoperative phase following TEP surgery compared to the conventional shouldice repair. Therefore, laparoscopic repair of inguinal hernia should not be seen as less traumatic than the conventional approach.

Low-dose IV lidocaine (typically 1.5-3 mg/kg/h) is easy to administer, has well-established analgesic, anti-hyperalgesic, and anti-inflammatory effects, and excellent safety record . Because postoperative pain is to a large extent an inflammatory phenomenon, administration of systemic local anesthetics, which have inflammatory modulatory properties, could significantly reduce pain and therefore allow more rapid discharge. In addition, intravenous lidocaine is an effective modality for treating visceral pain.

Objectives

Primary : To access the effect of perioperative lidocaine infusion on total morphine requirement during the first 24 h postoperatively in patients who underwent laparoscopic TEP for inguinal hernioplasty

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients with American Society of Anaesthesiologists physical status (ASA PS) I and II of age 18 to 65 years
  • Patients undergoing laparoscopic totally extraperitoneal repair for unilateral/bilateral inguinal hernia.

排除标准

  • Refusal to give consent.
  • ASA physical status III or more.
  • Inability to comprehend pain assessment score or severe mental impairment
  • Patient who weighed < 40 kg or >100 kg
  • Severe underlying cardiac rhythm disorder
  • Renal or hepatic disease
  • Allergic to local anaesthetics
  • Patients on regular analgesics or anti-arrhythmic drugs

研究组 & 干预措施

Lidocaine

Experimental

Lignocaine group (Group A) will receive an intravenous (IV) bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the tracheal extubation.

干预措施: Lidocaine (Drug)

Normal saline

Placebo Comparator

Normal saline group (Group B) will receive an intravenous normal saline bolus at induction followed by continuous infusion of normal saline until the tracheal extubation

干预措施: Normal saline (Drug)

结局指标

主要结局

Total morphine requirement during the first 24 h postoperatively

时间窗: 24h

次要结局

  • Quality of Recovery based on QoR-40 questionnaire at 24 h of the surgery.(24h)
  • Other side effects such as light headedness, tinnitus, perioral numbness, arrythmia and pruritus will be documented.(24h)
  • Patient satisfaction using Likert Satisfaction Scale at 24 h following surgery(24h)
  • Incidence of Chronic pain after TEP Repair(3 months)
  • Pain at rest and with coughing or movement using the NRS scale(24h)
  • Time to first perception of pain(24h)
  • Time to first voiding.(24h)
  • Incidence of postoperative nausea and vomiting (PONV) will be evaluated on a three-point ordinal scale.(24h)
  • Sedation score using five point scale(24h)

研究者

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

Dr. Anup Ghimire

Resident

B.P. Koirala Institute of Health Sciences

研究点 (1)

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