NCT07061678

The Effect of Dexamethasone Administration Route in Pediatric Brachial Plexus Block

The Effect of Dexamethasone Administration Route in Infraclavicular Brachial Plexus Block for Pediatric Arm and/or Hand Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Poznan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 3 Months – 6 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain and inflammatory response in pediatric patients undergoing hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate scale at multiple intervals. Secondary outcomes include inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, time-to-first rescue analgesia, and overall patient recovery. This randomized, double-blinded study seeks to improve pain management strategies and optimize anesthesia protocols in pediatric arm surgery.

Detailed description

Pediatric arm surgery is a complex procedure that can result in significant postoperative pain and an inflammatory response. Effective pain management is critical in this population to promote early mobilization, reduce opioid consumption, and minimize adverse outcomes. Dexamethasone is an adjuvant in regional anesthesia that prolongs analgesia and mitigates inflammation. However, the optimal administration route of dexamethasone in infraclavicular brachial plexus block for pediatric arm surgery remains unclear. This study is designed to compare the efficacy of intravenous versus perineural dexamethasone in prolonging postoperative analgesia and reducing inflammatory responses. This prospective, randomized, double-blinded clinical trial will enroll pediatric patients undergoing elective hip surgery. Participants will be randomized into two groups: one group will receive intravenous dexamethasone, while the other will receive perineural dexamethasone administered as part of the infraclavicular brachial plexus block. All patients will receive standardized spinal anesthesia under mild sedation and infraclavicular brachial plexus block using a local anesthetic at a fixed concentration. The primary outcome will be time to first request rescue analgesia. Secondary outcomes include the inflammatory response measured by NLR and PLR, postoperative pain intensity, assessed using an age-appropriate pain scale at predefined time intervals, total opioid consumption, and blood glucose levels. Safety will be closely monitored throughout the study, with particular attention to potential complications such as local anesthetic systemic toxicity (LAST) or dexamethasone-related adverse events.

Conditions

• Arm

Interventions

Type	Name	Description
DRUG	perineural dexamethasone	infraclavicular brachial plexus block with 0.2ml/kg 0.2% ropivacaine with 0.1mg/kg perineural dexamethasone
DRUG	intravenous dexamethasone	infraclavicular brachial plexus block with 0.2ml/kg 0.2% ropivacaine with 0.1mg/kg intravenous dexamethasone
DRUG	0.2ml/kg 0.2% ropivacaine	infraclavicular brachial plexus block with 0.2ml/kg 0.2% ropivacaine

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-12-30
• Completion: 2026-02-28
• First posted: 2025-07-11
• Last updated: 2025-11-25

Locations

2 sites across 1 country: Poland