Effect of Intravenous Dexamethasone With Pudendal Nerve Block on Postoperative Pain in Pediatric Hypospadias Repair

Phase 4

Completed

• Conditions: Hypospadias; Postoperative Pain
• Interventions: Drug: Dexamethasone

• Registration Number: NCT03902249
• Lead Sponsor: Dr Sonia ben khalifa (PhD)

Brief Summary

This study aims to determine if intravenous Dexamethasone combined with a pudendal nerve block is able to prolong postoperative analgesia in children undergoing hypospadias repair.

Detailed Description

It was a prospective study, randomized, double blind study, conducted at the Tunis Children's Hospital (January 2017-December 2018). After agreement with parents and the local ethics committee, the investigators included children aged 1 to 18 years, ASA 1-2, proposed for a hypospadias repair. Patients were randomized to: Group D receiving 0. 15mg/kg of Dexamethasone IV after induction and group P receiving the same volume of saline. The pudendal block was performed by neurostimulation after induction with Sevoflurane and 3 gamma/kg Fentanyl IV. The success of the block was tested at 10 and 15 minutes, it was declared successful when the systolic blood pressure and heart rate did not increase by more than 20% compared to the baseline values at the time of the incision. No analgesics were administered at the end of the surgery. The pain was assessed by the CHEOPS score the first 24 hours. The X2 test was used for qualitative variables and the student test for quantitative variables with P\<0. 05 as the significance threshold. The number of patients required for the study was calculated (alpha=5% beta=90%) and was 62.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-02
• Last Update Submitted: 2019-04-02
• Study First Posted: 2019-04-04
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

• ASA physical status classification 1 or 2
• Procedure: hypospadias repair
• Eligible for a pudendal nerve block

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Exclusion Criteria

• parents or patient refusal
• nerve block failure
• Peroperative complication.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Dexamethasone	Patients who received the same volume of saline as the study group (8ml)
Dexamethasone group	Dexamethasone	Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline

Primary Outcome Measures

Name	Time	Method
number of rescue analgesic consumption	The first 24 hours after surgery	Total number of rescue analgesic consumption for each patient
The mean time to first rescue analgesic	The first 24 hours after surgery	Time from the end of surgery to the first administration of rescue analgesic

Secondary Outcome Measures

Name	Time	Method
pain scores (CHEOPS)	Hour 0, Hour 1, Hour 2, Hour 3, Hour 4, Hour 8, Hour 12, Hour 24	CHEOPS score ranges from 4 to 13. 13 is the worst score. If the score was superior to 7 rescue analgesia was administrated.
Number of episodes of postoperative nausea and vomiting	The first 24 hours after surgery	Number of episodes of postoperative nausea and vomiting in each patient