Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?

Not Applicable

Completed

• Conditions: Pediatric Patients Undergoing Hypospadias Surgery
• Interventions: Drug: normal saline; Drug: dexamethasone

• Registration Number: NCT04836962
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Study Start: 2021-05-07
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	normal saline	normal saline is administrated to patients.
dexamethasone	dexamethasone	0.5mg/kg dexamethasone is administered to patients.

Primary Outcome Measures

Name	Time	Method
the duration from surgery to first PCA(patient-controlled analgesia) administration	during 48 hours after surgery	the very first time of PCA usage after surgery, which is automatically recorded in PCA.

Secondary Outcome Measures

Name	Time	Method
the amount of additional analgesia required for postoperative 48hrs.	during 48 hours after surgery	the amount of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA.
the number of additional analgesia required for postoperative 48hrs.	during 48 hours after surgery	the number of PCA usage for 48 hrs after surgery, which is automatically recorded in PCA.
pain score for each time period	during 48 hours after surgery	ask parents about their children's pain score at each time point
overall parents' satisfaction questionnaire	48 hours after surgery	at 48 hours after surgery, parents are asked about satisfaction of their children's pain control

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of