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

Primary Purpose

Elective Penile Surgeries, Hypospadias, Urethral Fistula or Stricture After Hypospadias Repair

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine
plain ropivacaine
Ropivacaine
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Elective Penile Surgeries focused on measuring dexmedetomidine, pudendal block, hypospadias

Eligibility Criteria

undefined - 6 Years (Child)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DR

PR

Arm Description

dexmedetomidine 0.3mcg/kg and 0.25% ropivacaine 0.3ml/kg

0.25% ropivacaine 0.3ml/kg

Outcomes

Primary Outcome Measures

1st analgesic request time
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

Postoperative pain evaluated by the FLACC scale
Postoperative pain is evaluated by the FLACC scale
Emergence delirium evaluated by the pediatric anesthesia emergence delirium scale
emergence delirium is evaluated by the pediatric anesthesia emergence delirium scale

Full Information

First Posted
July 5, 2016
Last Updated
July 15, 2018
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02848157
Brief Title
Effects of Dexmedetomidine as Adjunct to Pudendal Block for Pediatric Penile Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 17, 2016 (Actual)
Primary Completion Date
March 24, 2017 (Actual)
Study Completion Date
March 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elective Penile Surgeries, Hypospadias, Urethral Fistula or Stricture After Hypospadias Repair, Penile Curvature
Keywords
dexmedetomidine, pudendal block, hypospadias

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DR
Arm Type
Experimental
Arm Description
dexmedetomidine 0.3mcg/kg and 0.25% ropivacaine 0.3ml/kg
Arm Title
PR
Arm Type
Placebo Comparator
Arm Description
0.25% ropivacaine 0.3ml/kg
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
plain ropivacaine
Intervention Description
ropivacaine and normal saline equivalent doses of dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Primary Outcome Measure Information:
Title
1st analgesic request time
Description
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)
Time Frame
until 24 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative pain evaluated by the FLACC scale
Description
Postoperative pain is 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.
Title
Emergence delirium evaluated by the pediatric anesthesia emergence delirium scale
Description
emergence delirium is 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

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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