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

Phase 4

Completed

• Conditions: Elective Penile Surgeries; Hypospadias; Urethral Fistula or Stricture After Hypospadias Repair; Penile Curvature
• Interventions: Drug: plain ropivacaine; Drug: Dexmedetomidine; Drug: Ropivacaine

• Registration Number: NCT02848157
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-17
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-28
• Primary Completion: 2017-03-24
• Study Completion: 2017-03-24
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-15
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PR	plain ropivacaine	0.25% ropivacaine 0.3ml/kg
DR	Dexmedetomidine	dexmedetomidine 0.3mcg/kg and 0.25% ropivacaine 0.3ml/kg
DR	Ropivacaine	dexmedetomidine 0.3mcg/kg and 0.25% ropivacaine 0.3ml/kg

Primary Outcome Measures

Name	Time	Method
1st analgesic request time	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

Name	Time	Method
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	emergence delirium is evaluated by the pediatric anesthesia emergence delirium scale
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.	Postoperative pain is evaluated by the FLACC scale

Trial Locations

Locations (1)

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of