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

NCT ID: NCT03902249

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-12-31

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.

Conditions

Postoperative Pain; Hypospadias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dexamethasone group

Patients who received 0.15mg/kg of Dexamethasone in 8ml of saline

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Placebo group

Patients who received the same volume of saline as the study group (8ml)

Group Type: PLACEBO_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Interventions

Dexamethasone

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Dr Sonia ben khalifa (PhD)

OTHER

Sponsor Role: lead

Responsible Party

Dr Sonia ben khalifa (PhD)

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

References

Khalifa SB, Slimene AB, Blaiti H, Kaddour R, Hassen AF, Pardessus P, Brasher C, Dahmani S. The potentiating effect of intravenous dexamethasone upon preemptive pudendal block analgesia for hypospadias surgery in children managed with Snodgrass technique: a randomized controlled study : Dexamethasone for pain management in children. BMC Anesthesiol. 2024 Apr 16;24(1):145. doi: 10.1186/s12871-024-02536-3.

Reference Type: DERIVED

PMID: 38627668 (View on PubMed)

Other Identifiers

DexaProtocol

Identifier Type: -

Identifier Source: org_study_id