Clinical trial NCT04836962: Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?
Official title: Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Patients Undergoing Hypospadias Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 46
Sex: MALE
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypospadias is a congenital malformation that occurs in an embryological process, and occurs with an incidence of about 1/300 in male children. The caudal block was the most commonly performed method for pain control after hypospadias surgery, and showed very good analgesic effect in the immediate postoperative stage. However, the caudal block is a neuraxial block that has a limitation in its duration with single shot and shows complications and adverse effects. In recent studies, the pudendal nerve block has been suggested as an alternative method. In children undergoing hypospadias surgery, the pudendal nerve block showed a longer duration compared to the caudal block, decreased the use of analgesics within 24 hours after surgery, and showed higher parental satisfaction. On the other hand, there have been many studies to prolong the duration of the relatively short duration of caudal block. Among them, dexamethasone administered intravenously is known to improve the duration of various regional blocks and reduce the administration of additional analgesics. The aim of this study is to verify whether a single administration of dexamethasone can enhance the effect of the pudendal nerve block in children 0.5-3 years of age undergoing hypospadias surgery.


Eligibility criteria: Inclusion Criteria:

1. pediatric patients aged 6 months to 3 years who are planning to undergo hypospadias surgery
2. American Society of Anesthesiologists (ASA) classification 1\~2

Exclusion Criteria:

1. patients who are having uncorrected heart deformity
2. patients who are having vertebrae deformity in which the pudendal nerve block cannot be performed
3. patients with blood coagulopathy
4. patients with diagnosed diabetes
5. patients with diagnosed adrenal disease
6. patients with fever above 37.5 degrees before surgery
7. patients currently taking steroids
8. patients contraindicated for dexamethasone administration

Primary outcomes:
measure: the duration from surgery to first PCA(patient-controlled analgesia) administration
timeFrame: during 48 hours after surgery
Secondary outcomes:
measure: the amount of additional analgesia required for postoperative 48hrs.
timeFrame: during 48 hours after surgery
measure: the number of additional analgesia required for postoperative 48hrs.
timeFrame: during 48 hours after surgery
measure: pain score for each time period
timeFrame: during 48 hours after surgery
measure: overall parents' satisfaction questionnaire
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine
name: Jeong-Rim Lee
role: PRINCIPAL_INVESTIGATOR
References: