Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Caudal Epidural Block

Not Applicable

Recruiting

• Conditions: İnguinal Hernia
• Interventions: Drug: Dexmedetomidine; Drug: Dexamethasone

• Registration Number: NCT07056244
• Lead Sponsor: Sohag University

Brief Summary

The goal of This prospective, randomized, double-blind comparative study is to compare the efficacy of dexamethasone and dexmedetomidine as adjuvants to bupivacaine 0.125% in caudal epidural block for pediatrics undergoing inguinal hernia surgery, aged 2-6 years.

of Both sex.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-13
• Study First Submitted: 2025-06-29
• Study First Submitted QC: 2025-06-29
• Last Update Submitted: 2025-06-29
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Children aged 2-6 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I and II.
• Scheduled for inguinal hernia surgery

Exclusion Criteria

• Parents or legal gurdians refusal.
• Known hypersensitivity to any study drugs.
• Abnormal sacral anatomy
• Local infection at the injection site.
• Neurological disease.
• Coagulopathy.
• Mental retardation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A will receive Bupivacaine + Dexmedetomidine	Dexmedetomidine	Patients will receive Bupivacaine 0.125% at 0.5 ml/kg + Dexmedetomidine 1.5 mcg/kg for post operative analgesia.
group B will receive Bupivacaine + Dexamethasone	Dexamethasone	Patients will receive Bupivacaine 0.125% at 0.5 ml/kg + Dexamethasone 0.2 mg/kg for post operative analgesia.

Primary Outcome Measures

Name	Time	Method
duration of postoperative analgesia	Pain scores will be assessed at 15-minute intervals during the first two hours postoperatively, then at 4, 6, 8,12 and 24 hour.	compare the duration of postoperative analgesia between pediatric patients receiving bupivacaine 0.125% with either dexamethasone or dexmedetomidine as adjuvants

Secondary Outcome Measures

Name	Time	Method
rescue analgesia	Pain scores will be assessed at 15-minute intervals during the first two hours postoperatively, then at 4, 6, 8,12 and 24 hour.	To compare the requirement for rescue analgesia between the two groups (Group A: Bupivacaine + Dexmedetomidine vs. Group B: Bupivacaine + Dexamethasone ).

Trial Locations

Locations (1)

Sohag university Hospital; 🇪🇬 Sohag, Egypt