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

Hypospadias Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848157
• Other study ID #: 4-2016-0379
• Status: Completed
• Phase: Phase 4
• Start date: June 17, 2016
• Est. completion date: March 24, 2017

Study information

• Verified date: July 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 24, 2017
• Est. primary completion date: March 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 6 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• plain ropivacaine
ropivacaine and normal saline equivalent doses of dexmedetomidine
• Ropivacaine

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative pain evaluated by the FLACC scale	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.
Secondary	Emergence delirium evaluated by the pediatric anesthesia emergence delirium scale	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