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临床试验/NCT04869046
NCT04869046已完成4 期

Intraoperative Wound Instillation of Levobupivacaine is Effective in Postoperative Pain Management for Hernia Repair in Children: a Randomized Controlled Clinical Trial

Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年3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
发起方
入组人数
100
试验地点
2
主要终点
Postoperative pain assessment

研究概览

简要总结

The study analysed direct levobupivacaine instillation in surgical wound and its effectiveness in postoperative pain control. Half participants received 0,5 % levobupivacaine and the other half received 0,9% saline solution

详细描述

Inguinal hernia is one of the most common conditions that requires elective surgical repair in children. The issue of post-operative pain in children is important, particularly because the surgical intervention per se is a stressful experience, after which the level of stressors in the recovery period should be minimized. Stress, including the pain in the postoperative period, could contribute to a delayed postoperative wound healing and recovery. Also, untreated acute pain could interfere with cognitive function, immune response as well as lead to the development of chronic postsurgical pain. For this reason, it is vital to reduce the painful sensations over the postoperative period as much as possible.

Levobupivacaine is a long-acting local anesthetic. Evidence from animal models and human volunteer participants showed that levobupivacaine has favourable effects on cardiovascular and central nervous systems. Clinical studies have also showed that levobupivacaine has a very low risk of systemic toxicity. A combination of levobupivacaine with non-opioid analgesics could have a beneficial role in the postoperative recovery from inguinal hernia surgery in terms of pain relief. The purpose of this study was to examine the effectiveness of levobupivacaine instillation combined with the routine postoperative non-opioid analgesia in children who underwent inguinal hernia repair.

It is very important for children to leave the hospital without additional support. Instilled levobupivacaine applied directly to the wound, currently interrupting transmission of the painful stimuli from the site of major trauma. The dose of applied levobupivacaine in this study is 2 times lower than that administered for caudal block and 4 times lower than the maximum dose. Analgesic effectiveness of this procedure is measured by the frequency of administration of a mixture of ibuprofen and acetaminophen over 24 hours after surgery, and duration of time between the administration of two doses.

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
6 Months 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • elective surgery
  • not having incarcerated hernia
  • not having previous surgeries requiring general anaesthesia American Society of Anesthesia scores I and II
  • not having allergy to topical anesthetics, paracetamol, ibuprofen and/or general anesthetics, opioids or muscle relaxants

排除标准

  • worsening of health status prior to surgery
  • parental withdrawal to study

研究组 & 干预措施

Levobupivacaine group

Experimental

Instillation of 0,1 ml/kg (0,5 mg/kg) levobupivacaine 0,5% in surgical wound before fascia closure

干预措施: Instillation of levobupivacaine in surgical wound (Drug)

Control Group

Placebo Comparator

Instillation of 0,1 ml/kg 0,9% Sodium Chloride in surgical wound before fascia closure

干预措施: Instillation of levobupivacaine in surgical wound (Drug)

结局指标

主要结局

Postoperative pain assessment

时间窗: "Min 30" if no changes "Hour 6"

Assessment of pain by Face, Legs, Activity, Cry Consolability scale (nurse is observer) regularly, around the clock, first time 30 minutes after surgery, than after every 6 hours, until 24 h after surgery. Each score higher than 3 is considered significant and and an analgesic was given

Analgesic efficacy of nonopioid analgesic mixture

时间窗: as needed in 24 hours

30 minutes after taking analgesic mixture, the Face, Legs, Activity, Cry Consolability pain scale assessment was performed. Each score higher than 3 is considered significant and planed nonopioid analgesic was given. Frequency of nonsteroidal anti-inflammatory drug administration needed in 24 hour timeframe and time interval between doses were used as a measure of the analgesic effectiveness

次要结局

  • Control of breakthrough pain(as needed in 24 hours)

研究者

发起方
Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maja Sujica MD MS

Maja Sujica, Head of Department of Anesthesiology and Intensive Care

Institute for Mother and Child Health Care of Serbia "Dr Vukan Cupic"

研究点 (2)

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