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Completed

NCT Number: NCT02848157

Effects of Dexmedetomidine as Adjunct to Pudendal Block for Pediatric Penile Surgery

Caudal block is often performed to relieve postoperative pain in pediatric urological surgery. Recently, pudendal block is also used in penile surgery and it has advantage because of less side effects such as transient weakness of low extremities, but limited to use in penile surgery. Local anesthesia is a single shot injection, so additional analgesic drugs is required when the effect of local anesthetics are disappeared. Dexmedetomidine, an alpha adrenergic agonist, is commonly used in pediatric sedation. It has analgesic effect and potentiates the effect of local anesthetics. There are many studies about the potentiation of the effect of local anesthetics when added to dexmedetomidine in adults, it has been limited in pediatrics. Recent study said that local anesthetics with dexmedetomidine had prolonged duration of analgesia in caudal block, also in ilioinguinal block. Thus it is expected to have a prolonged effect when investigators use dexmedetomidine in pediatrics as well as adults.

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Key information

Conditions

Elective Penile Surgeries 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 Penile Curvature Penile Diseases Urethral Fistula or Stricture After Hypospadias Repair Urogenital Abnormalities Urogenital Diseases

Age range

Up to 6 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The patients aged between 6 months and 6 years in elective penile surgeries (hypospadias, urethral fistula or stricture after hypospadias repair, penile curvature)
  • American Society of Anesthesiologists (ASA) class I, II

Exclusion criteria

  • Coagulopathy
  • allergy to local anesthetics
  • meatal island onlay proximal transverse island flap (MIOPTI) (more than 4 h for the surgery)
  • illiteracy, foreigner

Treatment and study plan

Dexmedetomidine

Drug

Patients are put in lithotomy position. Two separate injection points are marked at 3 and 9 o'clock, about 2 to 2.5 cm from the center of anus. After aseptic preparation, a nerve stimulator needle advanced 1.5 to 3.5 cm perpendicular to the skin, and stimulation current is 2.5 to 5 mA. The unilateral contraction of anal sphincter means the inferior anal nerve stimulation. After reducing the current to 0.5 mA, the needle is then moved deeper until an up-and-down penile movement is observed. This is stimulation of the perineal branch of the pudendal nerve. Prepared drug (0.25% ropivacaine and 0.3 mcg/kg dexmedetomidine in the experimental group, and equivalent doses of ropivacaine and normal saline in the control group) is injected in half and half bilaterally.

plain ropivacaine

Drug

ropivacaine and normal saline equivalent doses of dexmedetomidine

Ropivacaine

Drug

Primary outcomes

  1. 1st analgesic request time

    Time frame: until 24 hours after surgery

    time to first rescue medication, assessed up to 24 h (time frame: from the administration of the pudendal block to the first registration of a FLACC≥4) (FLACC: face, legs, activity, cry, consolability)

Secondary outcomes

  1. Postoperative pain evaluated by the FLACC scale

    Time frame: The time of arrival in the recovery room, 10, 20, 30 min after arrival of the recovery room, and 4, 8, 12, 24 h after the surgery.

    Postoperative pain is evaluated by the FLACC scale

  2. Emergence delirium evaluated by the pediatric anesthesia emergence delirium scale

    Time frame: The time of arrival in the recovery room, 10, 20, 30 min after arrival of the recovery room, and through the time of discharge from the PACU, an average of 30 minutes

    emergence delirium is evaluated by the pediatric anesthesia emergence delirium scale

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2016
Registry last updated
Jul 17, 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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