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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02848157
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : July 17, 2018
Information provided by (Responsible Party):
Yonsei University

Brief 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.

Condition or disease Intervention/treatment Phase
Elective Penile Surgeries Hypospadias Urethral Fistula or Stricture After Hypospadias Repair Penile Curvature Drug: Dexmedetomidine Drug: plain ropivacaine Drug: Ropivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Actual Study Start Date : June 17, 2016
Actual Primary Completion Date : March 24, 2017
Actual Study Completion Date : March 24, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DR
dexmedetomidine 0.3mcg/kg and 0.25% ropivacaine 0.3ml/kg
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: Ropivacaine
Placebo Comparator: PR
0.25% ropivacaine 0.3ml/kg
Drug: plain ropivacaine
ropivacaine and normal saline equivalent doses of dexmedetomidine

Primary Outcome Measures :
  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 Outcome Measures :
  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

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02848157

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Korea, Republic of
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University Identifier: NCT02848157    
Other Study ID Numbers: 4-2016-0379
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yonsei University:
pudendal block
Additional relevant MeSH terms:
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Pathological Conditions, Anatomical
Penile Diseases
Urogenital Abnormalities
Congenital Abnormalities
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local