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Completed

NCT Number: NCT03496740

Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias

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.

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Key information

Conditions

Postoperative Pain Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hypospadias Male Urogenital Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Penile Diseases Postoperative Complications Signs and Symptoms Urogenital Abnormalities Urogenital Diseases

Age range

1 year–10 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University Hospital

İzmit, Kocaeli, 41340, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Penile Block

Procedure

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)

Pudendal Block

Procedure

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)

Bupivacaine (Block Drug)

Drug

Block drug

Primary outcomes

  1. Time to first analgesic

    Time frame: postoperative 7 day

    First need for rescue analgesic after the surgery will be recorded

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Ultrasound Guided Dorsal Penile Block vs Neurostimulator Guided Pudendal Block in Children Undergoing Hypospadias Surgery: A Prospective, Randomized, Double-Blind Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2018
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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