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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04836962
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Patients Undergoing Hypospadias Surgery	Drug: normal saline; Drug: dexamethasone	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Does the Single Use of Intravenous Dexamethasone Enhance Analgesic Quality of Pudendal Analgesia in Children Undergoing Hypospadias Surgery?
• Actual Study Start Date: May 7, 2021
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. pain score for each time period [during 48 hours after surgery]

   ask parents about their children's pain score at each time point

4. overall parents' satisfaction questionnaire [48 hours after surgery]

   at 48 hours after surgery, parents are asked about satisfaction of their children's pain control

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 3 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

• Principal Investigator: Jeong-Rim Lee, Department of Anesthesiology and Pain Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT04836962
• Other Study ID Numbers: 4-2021-0149
• First Posted: Apr 8, 2021
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypospadias; Dexamethasone

Study Results

No Results Posted as of Aug 23, 2022