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

NCT02848157 | Completed Phase 4

• 1 other identifier: 4-2016-0379
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

dexmedetomidine; pudendal block; hypospadias

Outcome Measures

Primary Outcomes (1)

• 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)

  until 24 hours after surgery

Secondary Outcomes (2)

• Postoperative pain 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

  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

Study Arms (2)

DR

EXPERIMENTAL

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

Drug: Dexmedetomidine; Drug: Ropivacaine

PR

PLACEBO COMPARATOR

0.25% ropivacaine 0.3ml/kg

Drug: plain ropivacaine

Interventions

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.

DR

plain ropivacaine DRUG

ropivacaine and normal saline equivalent doses of dexmedetomidine

PR

Ropivacaine DRUG

DR

Eligibility Criteria

• Age: Up to 6 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Hypospadias

Interventions

Dexmedetomidine; Ropivacaine

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 28, 2016
• Study Start: June 17, 2016
• Primary Completion: March 24, 2017
• Study Completion: March 24, 2017
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)