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

NCT02848157 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-07-17

No results posted yet for this study

Summary

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.

Conditions

  • Elective Penile Surgeries
  • Hypospadias
  • Urethral Fistula or Stricture After Hypospadias Repair
  • Penile Curvature

Interventions

DRUG

Dexmedetomidine

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.

DRUG

plain ropivacaine

ropivacaine and normal saline equivalent doses of dexmedetomidine

DRUG

Ropivacaine

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
6 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-17
Primary Completion
2017-03-24
Completion
2017-03-24

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02848157 on ClinicalTrials.gov