Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias

Overview

Pain after hypospadias surgery is a challenging issue to solve for anesthesists. Many different analgesia techniques were defined in literature for this purpose. The investigators have implemented application of ultrasound guided dorsal penile nerve block into practice for these type of surgeries. Main purpose of this study is to compare the efficacy of nerve stimulator guided pudendal nerve block with ultrasound guided dorsal penile nerve block for postoperative analgesia after hypospadias surgery.

Full Title of Study: “Ultrasound Guided Dorsal Penile Block vs Neurostimulator Guided Pudendal Block in Children Undergoing Hypospadias Surgery: A Prospective, Randomized, Double-Blind Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: November 23, 2018

Interventions

  • Procedure: Penile Block
    • Ultrasound guided dorsal penile nerve block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml)
  • Procedure: Pudendal Block
    • Nerve stimulation guided bilateral pudendal block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml)
  • Drug: Bupivacaine (Block Drug)
    • Block drug

Arms, Groups and Cohorts

  • Active Comparator: Penile Block
    • Ultrasound guided dorsal penile nerve block will be administered after general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks
  • Active Comparator: Pudendal Block
    • Nerve stimulator-guided pudendal block. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks

Clinical Trial Outcome Measures

Primary Measures

  • Time to first analgesic
    • Time Frame: postoperative 7 day
    • First need for rescue analgesic after the surgery will be recorded

Secondary Measures

  • Pain Scores
    • Time Frame: postoperative 48 hour
    • FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

Participating in This Clinical Trial

Inclusion Criteria

  • 1 to 10 years of age – ASA I-II – Undergoing elective hypospadias surgery Exclusion Criteria:

  • infection of the skin at the site of needle puncture area – patients with known allergies to any of the study drugs – coagulopathy – ASA III-IV – Patients with neurological disorders

Gender Eligibility: Male

male patients undergoing elective hypospadias surgery

Minimum Age: 1 Year

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kocaeli University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Can AKSU, Assistant Professor – Kocaeli University

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