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

April 2, 2019 updated by: Dr Sonia ben khalifa (PhD)

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone group
Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline
Placebo Comparator: Placebo group
Patients who received the same volume of saline as the study group (8ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mean time to first rescue analgesic
Time Frame: The first 24 hours after surgery
Time from the end of surgery to the first administration of rescue analgesic
The first 24 hours after surgery
number of rescue analgesic consumption
Time Frame: The first 24 hours after surgery
Total number of rescue analgesic consumption for each patient
The first 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scores (CHEOPS)
Time Frame: 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.
Hour 0, Hour 1, Hour 2, Hour 3, Hour 4, Hour 8, Hour 12, Hour 24
Number of episodes of postoperative nausea and vomiting
Time Frame: The first 24 hours after surgery
Number of episodes of postoperative nausea and vomiting in each patient
The first 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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