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

July 15, 2018 updated by: Yonsei University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DR
dexmedetomidine 0.3mcg/kg and 0.25% ropivacaine 0.3ml/kg
Drug: Ropivacaine
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.
Placebo Comparator: PR
0.25% ropivacaine 0.3ml/kg
Drug: plain ropivacaine
ropivacaine and normal saline equivalent doses of dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
until 24 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2016-0379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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