跳至主要内容
临床试验/NCT03563625
NCT03563625已完成不适用

The Effect of Local Wound Infiltration Versus Caudal Block on Wound Infection and Healing After Inguinal Herniotomy Paediatrics

University of Alexandria1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年11月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Wound healing will be assessed and will be given grades 0-5

研究概览

简要总结

The aim of the present study is to assess effect of local wound infiltration in comparison with caudal block by bupivacaine 0.25% after inguinal herniotomy in pediatrics on: Wound infection and healing (primary outcome) and postoperative analgesia (secondary outcome).

详细描述

THE EFFECT OF LOCAL WOUND INFILTERATION VERSUS CAUDAL BLOCK ON WOUND INFECTION AND HEALING AFTER INGUINAL HERNIOTOMY IN PAEDIATRICS

INTRODUCTION Since the introduction of cocaine in 1884, local anesthetics have been used as a mainstay of pain management. However, numerous studies over the past several decades have elucidated the supplemental role of local anesthetics as antimicrobial agents. In addition to their anesthetic properties, medications, such as: bupivacaine and lidocaine have been shown to exhibit bacteriostatic, bactericidal, fungistatic, and fungicidal properties against a wide spectrum of microorganisms.(1) Johnson et al.(2)made a comprehensive literature search using MEDLINE 1950-present for in vitro and in vivo studies pertaining to the antimicrobial activity of various local anaesthetics on a broad range of bacterial and fungal pathogens. Studies testing the effect on microbial growth inhibition of local anaesthetics alone and in combination with other agents, such as: preservatives and other medications, as well as the effect of conditions, such as: concentration and temperature were included for review. Evidence suggests that local anesthetics as a class possess inherent antimicrobial properties against a wide spectrum of human pathogens. Limited studies attribute the mechanism of action of antimicrobial activity of local anesthetics to a disruption of microbial cell membrane permeability, leading to leakage of cellular components and subsequent cell lysis.(2) Multiple local anesthetics at concentrations typically used in the clinical setting (e.g.:- bupivacaine 0.125%-0.75%; lidocaine 1%-3%) inhibit the growth of numerous bacteria and fungi under various conditions. Different local anesthetics showed various degrees of antimicrobial capacity; bupivacaine and lidocaine, for example, inhibit growth to a significantly greater extent than does ropivacaine.(2) In 1943 Lofgren (3) developed lidocaine. This was an amide and had a low risk of allergic reactions in comparison to ester local anesthetics. This was followed by mepivacaine (1957), prilocaine (1960), bupivacaine (1963), ropivacaine (1997) and levobupivacaine (2000).(3) Bupivacaine has been used in clinical practice for more than 40 years. It is remarkably stable in solution and is commercially available in 0.25% and 0.5% solutions (with and without epinephrine). Spinal heavy bupivacaine (0.5% bupivacaine + 6% glucose) is also manufactured. It is four times more potent than lidocaine. Therefore, 0.25% bupivacaine is equipotent with 1% lidocaine. Bupivacaine is particularly cardiotoxic and should never be used in Biers blocks. Bupivacaine binds tightly to tissues and thus has a long duration of action (up to 24 hours in some cases). Adding epinephrine will decrease its toxicity by delaying the drug absorption but, will have minimal effect on the duration of the block.(3)

The recommended maximum safe doses of bupivacaine are as follows:

BUPIVACAINE WITHOUT EPINEPHRINE ------- 2.0 mg/kg BUPIVACAINE WITH EPINEPHRINE ------- 2.5 mg/kg.(3) Caudal anesthesia is one of the most used-popular regional blocks in children. This technique is a useful adjunct during general anesthesia and for providing postoperative analgesia after infraumbilical operations. The quality and level of the caudal blockade is dependent on the dose, volume, and concentration of the injected drug.(4) Prophylactic analgesia with local anesthetics is an attractive concept, especially in pediatric practice, because the evaluation of pain can be very challenging in young children.(5) In contrast to opioids, local anesthetics can be administered safely, and in recent guidelines regional anaesthesia is accepted as the cornerstone of post-operative pain relief in the pediatric patients.(6) Although regional anaesthesia holds a good safety record overall, the global experience with pediatric regional anaesthesia is still quite low; even the most commonly performed procedure, caudal block, represents only 2.5% of all central neuroaxial blocks performed.(7,8) Determining the risk-benefit ratio is rather difficult for techniques that are relatively rarely performed. Wound infiltration can produce reliable analgesia for superficial skin surgery. Infiltration itself is extensively used by pediatricians, surgeons and emergency physicians for skin laceration repair or minor superficial surgery.(5) Several studies have compared the local anesthesia so far, including: ilio-inguinal and iliohypogastric nerve block plus subcutaneous injection by the surgeon against the caudal anesthesia.(9,10) But to our knowledge, there is still no study comparing the local wound infiltration by itself and caudal anesthesia for postoperative analgesia as regard their effect on wound infection and healing.

AIM OF THE WORK The aim of the present study is to assess effect of local wound infiltration in comparison with caudal block by bupivacaine 0.25% after inguinal herniotomy in pediatrics on: Wound infection and healing (primary outcome) and postoperative analgesia (secondary outcome).

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, Care Provider, Outcomes Assessor)

盲法说明

Blinded to procedure done

入排标准

年龄范围
2 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 2 months-1 year
  • Admitted for elective inguinal herniotomy surgery.

排除标准

  • History of developmental delay or mental retardation.
  • Diabetes mellitus type I.
  • Known allergy or contraindication to any local anesthetics.
  • Known congenital anomaly in the inguinal region.
  • Any patient who will develop any infections postoperatively (respiratory infection, urinary infection) other than wound infection will be excluded.

研究组 & 干预措施

Caudal block

Active Comparator

Caudal block with 1mg/kg bupivacaine 0.25%.

干预措施: Caudal block (Procedure)

Caudal block

Active Comparator

Caudal block with 1mg/kg bupivacaine 0.25%.

干预措施: Bupivacaine (Drug)

Wound infiltration

Active Comparator

Local wound infiltration with 1mg/kg bupivacaine 0.25%.

干预措施: Wound infiltration (Procedure)

Wound infiltration

Active Comparator

Local wound infiltration with 1mg/kg bupivacaine 0.25%.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Wound healing will be assessed and will be given grades 0-5

时间窗: 7 days

Wound healing will be assessed and will be given grades 0-5

次要结局

  • Pain score (Activity)(one day.)
  • Pain score (Cry)(one day.)
  • Pain score (Consolability)(one day.)
  • Pain score (Faces)(one day.)
  • Pain score (Legs)(one day.)

研究者

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

Mohammad Hazem I. Ahmad Sabry

Lecturer of Anesthesia

University of Alexandria

研究点 (1)

Loading locations...

相似试验

Local Wound Infiltration Versus Caudal Block on... | 临床试验