Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block
Condition: Distal Hypospadias
MeSH terms: Hypospadias; Fistula
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Ropivacaine; Fentanyl Citrate
Intervention type(s): Drug; Drug
Intervention description(s): Intraoperatively after induction of anaesthesia caudal epidural block will be administered with 0.2% ropivacaine 1-ml/kg; Intraoperatively after induction of anaesthesia fentanyl 1-mcg/kg/hour will be administered
Intervention MeSH terms: Fentanyl; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 30 male patients aged 1-8 years, ASA physical status I/II, and undergoing distal hypospadias repair will be randomly allocated to one of the following two groups:
GROUP I- (Caudal group, n= 15) Children will receive general anesthesia (GA) and analgesia will be maintained with caudal epidural block (CEB) with 0.2% ropivacaine:1 ml/kg.
GROUP II- (Non-caudal group, n= 15) Children will receive general anaesthesia (GA) and analgesia will be maintained with intravenous fentanyl citrate 1mcg/kg/hr.
roup-1 [CLADS Group, n=60]: Anaesthesia will be induced and maintained with propofol administered using the BIS feedback-based automated CLADS. Group-2 [Desflurane Group, n=60]: Anaesthesia will be induced with propofol CLADS and will be maintained intraoperatively by Desflurane titrated to BIS monitoring.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other