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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Patients Undergoing Hypospadias Surgery
• Intervention / Treatment: Drug: normal saline; Drug: dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University Health System, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: control; normal saline is administrated to patients.	Drug: normal saline; 2cc of normal saline is administered to patient instead of dexamethasone.
EXPERIMENTAL: dexamethasone; 0.5mg/kg dexamethasone is administered to patients.	Drug: dexamethasone; dexamethasone is administered 0.5mg/kg (up to 10mg) which is diluted with normal saline to make a total of 2cc.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Jeong-Rim Lee, Department of Anesthesiology and Pain Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2021
• Primary Completion (ACTUAL): January 31, 2022
• Study Completion (ACTUAL): January 31, 2022

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (ACTUAL): April 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Hypospadias; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 4-2021-0149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No