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临床试验/NCT03812731
NCT03812731已完成不适用

Incidence of Urethrocutaneous Fistula Following Distal Hypospadias Repair With and Without Caudal Epidural Block - A Pilot Study

Sir Ganga Ram Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年2月22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
30
试验地点
1
主要终点
Incidence of urethrocutaneous fistula

研究概览

简要总结

The study is designed to explore any association between the caudal epidural block(CEB) given for perioperative analgesia and the occurrence of urethrocutaneous fistula postoperatively in children undergoing distal hypospadias repair .We also intend to study the duration of penile engorgement due to CEB causing penile oedema which may subsequently play a role in fistula formation. The pilot study will recruit children under 8 years of age diagnosed with distal hypospadias scheduled to undergo Tubularised Incised Plate Urethroplasty, operated by a single paediatric surgeon. General anaesthesia will be induced with sevoflurane in oxygen nitrous oxide mixture supplemented by fentanyl citrate and atracurium besylate in all children. LMA Pro SealTMof appropriate size will be inserted. Children in group I will then be given caudal epidural block (CEB) as per our practice protocol. Children in group II will be given additional intravenous fentanyl citrate. All children will be followed postoperatively till 3 months to evaluate incidence of urethtocutaneous fistula. The prospective study attempts to eliminate previously reported confounding factors.

详细描述

CEB is routinely used along with general anaesthesia for inguinal and genital surgeries. It provides intraoperative and postoperative analgesia, is safe, simple and has success rate of more than 90% in children.It decreases the requirement of inhalational anaesthetics and narcotics, decreases stress hormone release and facilitates early recovery. Hypospadias is the most common congenital anomaly of penis, incidence being 1 in 300 live births. Hypospadias repair is a technical procedure that can be associated with significant complications such as meatal stenosis, stricture, glans dehiscence and flap necrosis Urethrocutaneous fisula formation is the most common complication after primary repair with an incidence of upto 20%. There have been controversies regarding the association of CEB with urethrocutaneous fistula. Some studies have reported a high incidence of postoperative urethrocutaneous fistula in children who received CEB while others have not confirmed any such relationship. Association between urethrocutaneous fistula and site of urethral opening, age of patient, duration of surgery, surgeon's expertise, use of subcutaneous epinephrine and use of preoperative testosterone has been found. Penile engorgement, post inflammatory response and tissue oedema may be contributory factors for development of fistula. However any association between CEB and fistula formation is not clear. All studies, except one, are retrospective, limited by small sample size and presence of various confounding factors. The present study is aimed to explore any association between CEB and urethrocutaneous fistula. The study will be conducted in children with distal hypospadias only; they will be operated by a single surgeon, without the use of subcutaneous epinephrine, so that any association, if at all between CEB and urethrocutaneous fistula becomes evident.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The attending anaesthesiologist will not be blinded to the technique utilised to administer GA. An independent assessor blinded to the technique of GA will follow up the patients to determine the incidence of uretherocutaneous fistula

入排标准

年龄范围
1 Year 至 8 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Male children l
  • 1 to 8 years of age
  • ASA physical status I and II
  • Distal hypospadias -

排除标准

  • Simultaneously undergoing any other procedure
  • Local infection in sacral region
  • Bleeding diathesis
  • Preoperative testosterone stimulation

研究组 & 干预措施

Caudal Group

Active Comparator

Children will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2 mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted.

Children in will then receive CEB with 0.2 % ropivacaine 1-ml/kg for maintaining analgesia

干预措施: Ropivacaine (Drug)

Non- Caudal Group

Active Comparator

Children will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2-mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted.

Children in will then receive fentanyl citrate 1-mcg/kg/hr for maintaining analgesia

干预措施: Fentanyl Citrate (Drug)

结局指标

主要结局

Incidence of urethrocutaneous fistula

时间窗: From one day after surgery(0-hours, baseline) till 3-months post surgery

Patients undergoing distal hypospadias repair will be followed up for occurrence of uretherocutaneous fistula

次要结局

  • Changes in intra-operative heart rate (beats per minute)(From beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively)
  • Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)(rom beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively)
  • Postoperative analgesia requirement(From end of anaesthesia (0-hours, baseline) till 24-hours postoperatively)
  • Penile Engorgement(After induction of anaesthesia (0-hours, baseline) till end of surgery)
  • Incidence of complications(From end of anaesthesia (0-hours, baseline) till 3-months postoperatively)

研究者

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

Dr Nitin Sethi

Associate Professor & Consultant

Sir Ganga Ram Hospital

研究点 (1)

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